A Phase 1/2 interventional study of Melphalan flufenamide (Melflufen) and Dexamethasone in Multiple Myeloma, sponsored by Oncopeptides AB. Terminated at 16 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-19.
Sponsored by Oncopeptides AB · Phase 1/2, Interventional, and Treatment
This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma to combination regimens of melflufen with currently approved agents. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 56 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Oncopeptides AB is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
defined as any of the following:
Adequate organ function with the following laboratory results during screening (within 21 days) and immediately before study drug administration on Cycle 1 Day 1:
Must have, or be willing to have an acceptable central catheter. (Port a cath, peripherally inserted central catheter [PICC] line, or central venous catheter)
Regimen A
Must be intolerant or to a prior IMiD; refractory defined as failure to respond (MR or better) or progression while on therapy or within 60 days of last dose.
Regimen B
Must have had a prior IMiD and a proteasome inhibitor (PI); alone or in combination and must be refractory or intolerant to an IMiD, PI or both.
Exclusion Criteria:
Prior treatment with melflufen
Regimen A
History of allergic reaction/ attributed to compounds containing boron, mannitol, polysorbate 80 or sodium citrate dihydrate
Regimen B
Active hepatitis B (defined as HBsAg+) or those at risk for reactivation (HBsAg-, Anti- HBs+, Anti-HBc+)
Patients with prior hepatitis B vaccine are permitted (defined as HBsAg-, Anti-HBs+, Anti-HBc-)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Melflufen 30 mg and 40 mg or 20 mg i.v. Day 1 of each 28-day cycle in combination with bortezomib at 1.3mg/m² S.Q. on Days 1, 4, 8, 11 and dexamethasone 20 mg (12 mg ≥ 75 years) Days 1, 4, 8, 11 and 40 mg (20 mg ≥ 75 years) on Day 15 and 22 of each 28-day cycle.
Drug: Melphalan flufenamide (Melflufen) · Drug: Dexamethasone · Drug: Bortezomib
Melflufen 30 mg and 40 mg or 20 mg i.v. Day 1 of each 28-day cycle in combination with daratumumab 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Dexamethasone p.o. 40 mg weekly (20 mg weekly for patients age ≥ 75 years).
Drug: Melphalan flufenamide (Melflufen) · Drug: Dexamethasone · Drug: Daratumumab
Intravenous infusion
Oral tablets
Also known as: Dex, Fortecortin, Decadron
Subcutaneous administration
Also known as: Velcade
Intravenous infusion
Also known as: Dara, Darzalex
Phase 1: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Toxicity was graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 4.03. DLT criteria that apply to Regimens A and B: * Grade 3 non-hematologic toxicity preventing the administration of \> 1 dose of bortezomib or daratumumab during the 1st cycle. * Grade 4 or greater non-hematologic toxicity. * Grade 4 thrombocytopenia (platelet count \< 25,000 cells/ mm\^3) preventing the administration of \> 1 dose of bortezomib or daratumumab during the 1st cycle or with clinically significant bleeding during the 1st cycle. * Grade 4 neutropenia (ANC \< 500 cells/mm\^3), lasting more than 7 days during the 1st cycle. * Greater than 14 days' delay to meet the criteria for the start of a new cycle (Cycle 2) due to toxicity.
Time frame: Cycle 1: Day 1 to Day 28
Phase 2: Overall Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a best confirmed response of Partial Response (PR) or better.
Time frame: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
Best Response (BR)
BR defined by International Myeloma Working Group Uniform Response Criteria. BR= Complete Response (CR)/Stringent CR (sCR) defined as below negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow/plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, Very Good Partial Response (VGPR)= serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 hours, Partial Response (PR)= a \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \> 90% or to \< 200 mg/24 hours, Minimal Response (MR), Stable Disease (SD)= not meeting the criteria for other response options, Progressive Disease (PD)= increase of \> 25% from lowest response value in serum/urine M-component or bone marrow plasma cell percentage, or non-evaluable.
Time frame: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
Duration of Response (DOR)
DOR is defined for participants with confirmed objective response (PR or better, which includes PR, VGPR, CR and sCR) as the time from the first documentation of objective response to the first documentation of objective progression or to death due to any cause, whichever occurs first.
Time frame: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
Time to Response (TTR)
Time from Cycle 1 Day 1 to a response of PR or better.
Time frame: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
Progression-Free Survival (PFS)
PFS was defined as the time in months from date of initiation of therapy to the earlier of confirmed disease progression or death due to any cause.
Time frame: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
Overall Survival (OS)
Time from the first dose of melflufen to death due to any cause.
Time frame: Up to 24 months following confirmed disease progression, or initiation of subsequent therapy (a maximum of 198.9 weeks)
Duration of Clinical Benefit (DOCB)
DOCB was defined as time in months from the first evidence of confirmed assessment of sCR, CR, VGPR, PR or MR to first confirmed disease progression, or to death due to any cause.
Time frame: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
Time to Progression (TTP)
TTP defined as time from first dose to first documented confirmed progression.
Time frame: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
Clinical Benefit Rate (≥ Minimal Response)
≥ Minimal response for participants included sCR, CR, VGPR, PR and MR.
Time frame: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
Time to Next Treatment (TTNT)
Defined as time from date of initiation of therapy to start of next line of therapy.
Time frame: Until death or initiation of subsequent therapy (a maximum of 194.3 weeks)
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs were defined as adverse events (AEs) that started after the first dose of study medication was administered and within 30 days of the last administration of the study treatment or before start of subsequent anticancer treatment (whichever occurred first) or that worsened after the first dose of study medication was administered.
Time frame: Cycle 1 Day 1 up to a maximum of 198.9 weeks
56 participants were enrolled across 13 sites in the Czech Republic, France, Spain and the United States.
| Milestone | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone |
|---|---|---|---|---|
| Started | 15 | 8 | 6 | 27 |
| Completed | 0 | 1 | 1 | 2 |
| Not completed | 15 | 7 | 5 | 25 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
| Withdrew: Death | 4 | 2 | 3 | 16 |
| Withdrew: Study terminated by sponsor | 10 | 5 | 2 | 9 |
Toxicity was graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 4.03. DLT criteria that apply to Regimens A and B: * Grade 3 non-hematologic toxicity preventing the administration of \> 1 dose of bortezomib or daratumumab during the 1st cycle. * Grade 4 or greater non-hematologic toxicity. * Grade 4 thrombocytopenia (platelet count \< 25,000 cells/ mm\^3) preventing the administration of \> 1 dose of bortezomib or daratumumab during the 1st cycle or with clinically significant bleeding during the 1st cycle. * Grade 4 neutropenia (ANC \< 500 cells/mm\^3), lasting more than 7 days during the 1st cycle. * Greater than 14 days' delay to meet the criteria for the start of a new cycle (Cycle 2) due to toxicity.
| Participants | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone |
|---|---|---|---|---|
| Phase 1: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | 0 | 0 | 0 | 0 |
ORR was defined as the percentage of participants who achieved a best confirmed response of Partial Response (PR) or better.
| percentage of participants | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone |
|---|---|---|---|---|
| Phase 2: Overall Response Rate (ORR) | 80 (51.9 to 95.7) | 75 (34.9 to 96.8) | 83.3 (35.9 to 99.6) | 70.4 (49.8 to 86.2) |
BR defined by International Myeloma Working Group Uniform Response Criteria. BR= Complete Response (CR)/Stringent CR (sCR) defined as below negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow/plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, Very Good Partial Response (VGPR)= serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 hours, Partial Response (PR)= a \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \> 90% or to \< 200 mg/24 hours, Minimal Response (MR), Stable Disease (SD)= not meeting the criteria for other response options, Progressive Disease (PD)= increase of \> 25% from lowest response value in serum/urine M-component or bone marrow plasma cell percentage, or non-evaluable.
| Participants | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone |
|---|---|---|---|---|
| CR | 1 | 0 | 1 | 1 |
| sCR | 0 | 1 | 0 | 1 |
| VGPR | 2 | 3 | 2 | 6 |
| PR | 9 | 2 | 2 | 11 |
| MR | 1 | 0 | 0 | 1 |
| SD | 1 | 1 | 0 | 2 |
| PD | 0 | 0 | 0 | 1 |
| Non-evaluable | 0 | 0 | 0 | 0 |
| Missing | 1 | 1 | 1 | 4 |
DOR is defined for participants with confirmed objective response (PR or better, which includes PR, VGPR, CR and sCR) as the time from the first documentation of objective response to the first documentation of objective progression or to death due to any cause, whichever occurs first.
| months | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| Duration of Response (DOR) | 9.0 (4.9 to NA) | NA (NA to NA) | 24.2 (10.60 to NA) | 9.9 (7.2 to 14.8) |
Time from Cycle 1 Day 1 to a response of PR or better.
| months | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| Time to Response (TTR) | 3.0 (1.0 to 8.6) | 2.2 (1.0 to 4.6) | 3.3 (1.0 to 4.2) | 1.1 (0.9 to 5.3) |
PFS was defined as the time in months from date of initiation of therapy to the earlier of confirmed disease progression or death due to any cause.
| months | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| Progression-Free Survival (PFS) | 10.0 (7.5 to 33.5) | 24.30 (2.90 to NA) | 28.4 (14.3 to NA) | 9.7 (6.7 to 14.2) |
Time from the first dose of melflufen to death due to any cause.
| months | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| Overall Survival (OS) | 33.5 (9.00 to NA) | NA (NA to NA) | 35.0 (6.4 to NA) | 18.3 (14.29 to NA) |
DOCB was defined as time in months from the first evidence of confirmed assessment of sCR, CR, VGPR, PR or MR to first confirmed disease progression, or to death due to any cause.
| months | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| Duration of Clinical Benefit (DOCB) | 15.7 (7.6 to NA) | 21.3 (13.7 to NA) | 27.20 (13.10 to NA) | 10.9 (8.40 to 14.50) |
TTP defined as time from first dose to first documented confirmed progression.
| months | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| Time to Progression (TTP) | 17.6 (7.5 to NA) | 24.3 (2.90 to NA) | 29.2 (14.3 to NA) | 11.5 (7.7 to 15.4) |
≥ Minimal response for participants included sCR, CR, VGPR, PR and MR.
| percentage of participants | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| Clinical Benefit Rate (≥ Minimal Response) | 86.7 (59.5 to 98.3) | 75.0 (34.9 to 96.8) | 83.3 (35.9 to 99.6) | 74.1 (53.7 to 88.9) |
Defined as time from date of initiation of therapy to start of next line of therapy.
| months | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| Time to Next Treatment (TTNT) | 33.50 (9.0 to NA) | 14.70 (3.90 to NA) | 26.25 (2.3 to NA) | 9.5 (5.6 to 13.4) |
TEAEs were defined as adverse events (AEs) that started after the first dose of study medication was administered and within 30 days of the last administration of the study treatment or before start of subsequent anticancer treatment (whichever occurred first) or that worsened after the first dose of study medication was administered.
| Participants | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| Any TEAEs | 15 | 8 | 6 | 27 |
| Any Grade 3 or Higher TEAEs | 15 | 8 | 6 | 26 |
Collected over Cycle 1 Day 1 up to a maximum of 198.9 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A (Melflufen+Bortezomib+Dex) 30 mg | 4/15 (26.7%) | 9/15 (60%) | 15/15 (100%) |
| A (Melflufen+Bortezomib+Dex) 40 mg | 2/8 (25%) | 5/8 (62.5%) | 8/8 (100%) |
| B (Melflufen+Daratumumab+Dex) 30 mg | 3/6 (50%) | 4/6 (66.7%) | 6/6 (100%) |
| B (Melflufen+Daratumumab+Dex) 40 mg | 16/27 (59.3%) | 11/27 (40.7%) | 27/27 (100%) |
| Event | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| InfluenzaInfections and infestations | 0/15 | 0/8 | 2/6 | 1/27 |
| PneumoniaInfections and infestations | 2/15 | 0/8 | 1/6 | 3/27 |
| COVID-19 pneumoniaInfections and infestations | 2/15 | 1/8 | 1/6 | 0/27 |
| SepsisInfections and infestations | 0/15 | 0/8 | 1/6 | 1/27 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/15 | 0/8 | 1/6 | 1/27 |
| Humerus fractureInjury, poisoning and procedural complications | 2/15 | 0/8 | 1/6 | 0/27 |
| Urinary tract infectionInfections and infestations | 0/15 | 1/8 | 0/6 | 2/27 |
| InfectionInfections and infestations | 0/15 | 1/8 | 0/6 | 1/27 |
| BronchitisInfections and infestations | 0/15 | 1/8 | 0/6 | 0/27 |
| DiverticulitisInfections and infestations | 0/15 | 1/8 | 0/6 | 0/27 |
| Event | A (Melflufen+Bortezomib+Dex) 30 mg | A (Melflufen+Bortezomib+Dex) 40 mg | B (Melflufen+Daratumumab+Dex) 30 mg | B (Melflufen+Daratumumab+Dex) 40 mg |
|---|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 13/15 | 8/8 | 6/6 | 17/27 |
| NeutropeniaBlood and lymphatic system disorders | 11/15 | 7/8 | 6/6 | 17/27 |
| AnaemiaBlood and lymphatic system disorders | 10/15 | 6/8 | 5/6 | 16/27 |
| Upper respiratory tract infectionInfections and infestations | 4/15 | 2/8 | 4/6 | 6/27 |
| Urinary tract infectionInfections and infestations | 3/15 | 1/8 | 3/6 | 3/27 |
| InfectionInfections and infestations | 4/15 | 3/8 | 3/6 | 1/27 |
| NasopharyngitisInfections and infestations | 1/15 | 1/8 | 3/6 | 1/27 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/15 | 0/8 | 3/6 | 3/27 |
| FatigueGeneral disorders | 5/15 | 2/8 | 2/6 | 11/27 |
| Soft tissue infectionInfections and infestations | 0/15 | 3/8 | 0/6 | 0/27 |
Participants included in the Safety Analysis Set were included in the Baseline Characteristics. The Safety Analysis Set includes all patients that have received at least 1 dose (or partial dose) of melflufen, dexamethasone, or partner therapy (bortezomib or daratumumab).
| Age, Continuous(years) | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | Total |
|---|---|---|---|---|---|
| Mean | 69.7 ± 8.17 | 69.4 ± 5.13 | 60.5 ± 12.13 | 62.3 ± 11.15 | 65.1 ± 10.35 |
| Sex: Female, Male(Participants) | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | Total |
|---|---|---|---|---|---|
| Female | 7 | 1 | 3 | 8 | 19 |
| Male | 8 | 7 | 3 | 19 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 0 | 1 |
| Not Hispanic or Latino | 14 | 8 | 6 | 23 | 51 |
| Unknown or Not Reported | 0 | 0 | 0 | 4 | 4 |
| Race (NIH/OMB)(Participants) | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 2 | 2 |
| White | 15 | 8 | 6 | 21 | 50 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 4 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Feb 2022, 45 months.
Results were first posted in Dec 2022, 10 months after primary completion.
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