A Phase 2 interventional study of Ixazomib and Daratumumab in Multiple Myeloma, sponsored by Takeda. Completed at 28 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Takeda · Phase 2, Interventional, and Treatment
Among 68 studies testing ixazomib in Multiple Myeloma — 1 open to participants now, 7 under way, none of them phase 3. ixazomib · Multiple Myeloma.
Among the 68 studies testing ixazomib in Multiple Myeloma, this one is the 26th largest by enrollment, is one of 8 that started in 2018, is one of 38 in phase 2, and was the 45th registered.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
Browse Multiple Myeloma studies →1 of the 68 studies testing ixazomib in Multiple Myeloma is open now, in 1 country. Recruiting first, the newest first:
Second Affiliated Hospital, School of Medicine, Zhejiang University · Sites in China
By country, each count listing its studies:
ixazomib: first FDA approval 2015 (NINLARO), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →
Of the 584 Multiple Myeloma studies recruiting now, 429 (73%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
68 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 47 · Phase 3 8 · Phase 4 4
First in 2009; this study’s year is marked. 8 started in 2018.
This study's enrollment of 61 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Median enrollment 48 across the 68 interventional studies. Of the 55 that completed or were terminated, 38 (69%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 68 have an industry lead sponsor. The 10 most frequent:
Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
27 studies in Multiple Myeloma by Takeda: 2 open now, 4 under way, 1 of them phase 3. Of 21 finished, 15 (71%) have results posted.
Among the 27 studies in Multiple Myeloma by Takeda, this one is the 6th largest by enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2018, is one of 4 in phase 2, and was the 12th registered.
Takeda’s Multiple Myeloma studies by the year they started, since 2012.
2 of the studies testing ixazomib in Multiple Myeloma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04009109Alliance Foundation Trials, LLC.Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM | 2026-12 |
| NCT03763162M.D. Anderson Cancer CenterDaratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma | 2027-10-30 |
Among the 68 studies testing ixazomib in Multiple Myeloma, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Takeda’s 27 in Multiple Myeloma:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the percentage of participants with a response of very good partial response (VGPR) or better to IDd treatment.
The regimen being tested in this study is the combination of ixazomib, daratumumab, and dexamethasone. This study will look at the efficacy and safety of IDd in people who have RRMM.
The study will enroll approximately 60 Participants. Participants will be assigned to the treatment group:
All participants will be asked to take Ixazomib on Days 1, 8 and 15 of each 28-day cycle plus Daratumumab on Days 1, 8, 15 and 22 of each 28-day cycle for Cycles 1 and 2, on Days 1 and 15 of each 28-day cycle for Cycles 3 through 6 and on Day 1 of each 28-day cycle for Cycle 7 and beyond plus Dexamethasone orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle.
This multi-center trial will be conducted in the United States, Czech Republic, France, Poland, Greece and the Netherlands. The overall time to participate in this study is approximately 5 years. Participants will make multiple visits to the clinic, and every 12 weeks after PD until death or termination of the study by the sponsor.
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.
Have by at least 1 of the following measurements:
Must meet the following laboratory criteria:
Exclusion Criteria:
With known (COPD) with a (FEV1) \<50% of predicted normal. Note: FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \<50% of predicted normal.
With ongoing or active systemic infection requiring intravenous IV medical management ; participants with known - Ribonucleic acid (HIV-RNA) positivity; participants with virus (HBV) surface antigen or core antibody positivity; and participants with known virus-RNA positivity. Note: Participants who have positive hepatitis B core antibody can be enrolled but must have hepatitis B virus- deoxyribonucleic acid (DNA) negative. Participants who have positive hepatitis C antibody can be enrolled but must have hepatitis C virus-RNA negativity.
Note: Participants who are already enrolled at the time of Amendment 02 should have local HBV testing performed as soon as possible for HBV surface antigen, e antigen, core antibody, and DNA. If any of these tests is positive, consult a physician with expertise in managing HBV for guidance regarding stopping daratumumab, starting HBV antiviral therapy, and remaining on study.
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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
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.
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.
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.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.
Drug: Ixazomib · Drug: Daratumumab · Drug: Dexamethasone
Ixazomib capsule.
Also known as: NINLARO
Daratumumab IV infusion.
Dexamethasone tablets.
Percentage of Participants With Very Good Partial Response (VGPR) or Better (Complete Response + VGPR)
Response was assessed using International Myeloma Working Group (IMWG) Criteria. VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours. The percentage of participants were rounded off to the single decimal point.
Time frame: Up to 5 years
Progression-free Survival (PFS)
PFS is defined as time from date of first dose of drug to date of first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Participant without documentation of PD or death were censored at the date of last response assessment that is stable disease (SD) or better. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. SD is defined as not meeting criteria for other responses.
Time frame: Up to 5 years
Time to Progression (TTP)
TTP is defined as the time from the first dose of any study drug treatment to the date of the first documented PD. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time frame: Up to 5 years
Overall Survival (OS)
OS is defined as the time from the date of first dose of any study drug treatment to the date of death. Participant without documentation of death at the time of analysis will be censored at the last visit at which s/he was known to be alive.
Time frame: Up to 5 years
Overall Response Rate (ORR)
ORR is defined as percentage of participants with complete response (CR), VGPR and partial response (PR). CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; normal free light chain (FLC) ratio of 0.26-1.65; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24 hours; and PR: \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions. The percentage of participants were rounded off to the single decimal point.
Time frame: Up to 5 years
Time To Response (TTR)
TTR is defined as the time from first dose of any study drug treatment to the date of first documentation of PR or better. PR is defined as \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions.
Time frame: Up to 5 years
Duration of Response (DOR)
DOR is defined as the time from the date of first documentation of PR or better to the date of the first documented PD among participants who responded to the treatment.
Time frame: Up to 5 years
Participants took part in the study at investigative sites in Greece, the Czech Republic, the United States, Poland, France and the Netherlands from 13 March 2018 to 26 June 2023.
| Milestone | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Started | 61 |
| Response-evaluable population | 59 |
| Completed | 0 |
| Not completed | 61 |
| Withdrew: Death | 22 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Reason not specified | 28 |
| Withdrew: Missing | 1 |
Response was assessed using International Myeloma Working Group (IMWG) Criteria. VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours. The percentage of participants were rounded off to the single decimal point.
| percentage of participants | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Percentage of Participants With Very Good Partial Response (VGPR) or Better (Complete Response + VGPR) | 32.2 (20.62 to 45.64) |
PFS is defined as time from date of first dose of drug to date of first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Participant without documentation of PD or death were censored at the date of last response assessment that is stable disease (SD) or better. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. SD is defined as not meeting criteria for other responses.
| months | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Progression-free Survival (PFS) | 16.8 (10.1 to 23.7) |
TTP is defined as the time from the first dose of any study drug treatment to the date of the first documented PD. PD is defined as increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/dl); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dl); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
| months | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Time to Progression (TTP) | 21.1 (10.2 to 27.9) |
OS is defined as the time from the date of first dose of any study drug treatment to the date of death. Participant without documentation of death at the time of analysis will be censored at the last visit at which s/he was known to be alive.
| months | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Overall Survival (OS) | NA (NA to NA) |
ORR is defined as percentage of participants with complete response (CR), VGPR and partial response (PR). CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; normal free light chain (FLC) ratio of 0.26-1.65; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24 hours; and PR: \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions. The percentage of participants were rounded off to the single decimal point.
| percentage of participants | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Overall Response Rate (ORR) | 66.1 |
TTR is defined as the time from first dose of any study drug treatment to the date of first documentation of PR or better. PR is defined as \>=50% reduction of serum M protein and reduction in 24-hour urinary M protein by \>=90%/to \<200 mg/24 hours; In addition, if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; no known evidence of progressive/new bone lesions.
| months | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Time To Response (TTR) | 2.7 (1.9 to 5.8) |
DOR is defined as the time from the date of first documentation of PR or better to the date of the first documented PD among participants who responded to the treatment.
| months | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Duration of Response (DOR) | 24.0 (15.9 to NA) |
Collected over Up to 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg | 22/61 (36.1%) | 28/61 (45.9%) | 58/61 (95.1%) |
| Event | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| PneumoniaInfections and infestations | 6/61 |
| COVID-19 pneumoniaInfections and infestations | 3/61 |
| Acute kidney injuryRenal and urinary disorders | 2/61 |
| AnaemiaBlood and lymphatic system disorders | 2/61 |
| COVID-19Infections and infestations | 2/61 |
| GastroenteritisInfections and infestations | 2/61 |
| Urinary tract infectionInfections and infestations | 2/61 |
| Back painMusculoskeletal and connective tissue disorders | 1/61 |
| Bone painMusculoskeletal and connective tissue disorders | 1/61 |
| BronchitisInfections and infestations | 1/61 |
| Event | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| DiarrhoeaGastrointestinal disorders | 26/61 |
| AnaemiaBlood and lymphatic system disorders | 17/61 |
| ThrombocytopeniaBlood and lymphatic system disorders | 16/61 |
| FatigueGeneral disorders | 15/61 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 14/61 |
| Back painMusculoskeletal and connective tissue disorders | 14/61 |
| NauseaGastrointestinal disorders | 13/61 |
| ConstipationGastrointestinal disorders | 10/61 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 10/61 |
| Oedema peripheralGeneral disorders | 10/61 |
Safety population included participants who received at least 1 dose of any study treatment regimen.
| Age, Continuous(years) | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Mean | 67.8 ± 7.80 |
| Sex: Female, Male(Participants) | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Female | 29 |
| Male | 32 |
| Ethnicity (NIH/OMB)(Participants) | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 55 |
| Unknown or Not Reported | 5 |
| Race (NIH/OMB)(Participants) | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 53 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
| Height(centimeters (cm)) | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Mean | 166.8 ± 8.71 |
| Weight(kilograms (kg)) | Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg |
|---|---|
| Mean | 80.08 ± 17.625 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Mar 2018 to primary completion in Jan 2022, 45 months.
Results were first posted in Feb 2023, 1 year 1 month after primary completion.
Of 93 industry-sponsored phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 77. This study's 45 months is above that.
Counting every sponsor, half of 505 studies reached it within 57 months; a quarter within 35 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ixazomib · Daratumumab · Dexamethasone