A Phase 2 interventional study of Pomalidomide and Dexamethasone in Multiple Myeloma, sponsored by Celgene. Completed at 49 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 2, Interventional, and Treatment
This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy.
This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide.
This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide.
This trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of >60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.
A phase 2, multicenter, multi-cohort, open-label study of pomalidomide in combination with low-dose dexamethasone or pomalidomide in combination with low-dose dexamethasone and daratumumab in subjects with relapsed or refractory multiple myeloma following lenalidomide based therapy in the first or second line setting.
This trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 186 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.
First submitted before Celgene became part of Bristol-Myers Squibb.
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.
Subjects must satisfy the following criteria to be enrolled in the study:
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment:
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Any of the following laboratory abnormalities:
Prior history of , other than MM, unless the subject has been free of the disease for more than 5 years. Allowed exceptions include the following:
•Basal or squamous cell carcinoma of the skin
•Carcinoma in situ of the cervix or breast
Subjects with any one of the following:
Subjects who received any of the following within 14 days of initiation of study treatment:
Known (HIV) positivity; active infectious hepatitis A, B, or C; or chronic or C
All subjects will be tested for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (antiHBs), and hepatitis B core antibody (antiHBc). Subjects with the following serological testing are considered not eligible:
Note:
All subjects will be tested for antibody. Subjects are not eligible if known seropositive for hepatitis C virus.
Note:
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.
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.
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.
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.
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).
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each subject enrolled in the study will take oral pomalidomide (4 mg) once daily on Days 1-21 and dexamethasone 40 mg/day (\< 75 years old) or 20 mg/day (\>75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.
Drug: Pomalidomide · Drug: Dexamethasone
Each subject enrolled in the study will take oral pomalidomide (4 mg) once daily on Days 1-21 and dexamethasone 40 mg/day (\< 75 years old) or 20 mg/ day (\>75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle and daratumumab administered intravenously (IV) at a starting dose of 16 mg/kg at following schedule: * Days 1, 8, 15, and 22 of a 28-day cycle for Cycle 1 and Cycle 2 * Days 1 and 15 for Cycle 3 through Cycle 6 * Day 1 for Cycle 7 and each cycle thereafter until disease progression
Drug: Pomalidomide · Drug: Dexamethasone · Drug: Daratumumab
Also known as: CC-4047
Also known as: dex
Overall Response Rate (ORR)
ORR per Modified International Myeloma Working Group (mIMWG) Criteria is defined as the percentage of participants who achieve best overall response of Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours
Time frame: From first dose until disease progression or end of treatment whichever occurs first (Up to 130 months)
Progression Free Survival (PFS)
PFS is defined as the time from the first dose to the first documentation of disease progression according to modified International Myeloma Working Group (mIMWG) criteria or death from any cause, whichever occurs first. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. Based on Kaplan-Meier Estimates.
Time frame: From first dose until the first documented disease progression, or death whichever occurs first (Up to 130 months)
Overall Survival (OS)
OS is defined as the time from start of treatment until the time of death from any cause. If no death is recorded the subject will be censored at the time the subject was last known to be alive. Based on Kaplan-Meier Estimates
Time frame: From first dose until death due to any cause (Up to 130 months)
Duration of Response (DoR)
DoR is defined as thr time from the initial documented response (partial response or better) to the first confirmed progressive disease or until death from any cause. Participants without documented progression will be censored at the time of their last response assessment. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours. Based on Kaplan-Meier Estimates
Time frame: From first dose until the first documented disease progression, or death whichever occurs first (Up to 130 months)
Time to Response (TTR)
TTR is defined as the time from the start of treatment to the first documented response (Partial Response, Very Good Partial Response or Complete Response) based on according to modified International Myeloma Working Group (mIMWG) criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours. Based on Kaplan-Meier Estimates
Time frame: From first dose until the first documented response (Up to 130 months)
Time to Progression (TTP)
TTP is defined as the time from start of treatment until Progressive Disease (as determined by the site investigator according to modified International Myeloma Working Group (mIMWG) criteria). Participants not experiencing a documented progression will be censored at the time of their last response assessment. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. Based on Kaplan-Meier Estimates
Time frame: From first dose until the first documented disease progression whichever occurs first (Up to 130 months)
Number of Participants With Treatment Emergent Adverse Events (AEs)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Time frame: From first dose until 28 days post last dose (Up to 120 months)
| Milestone | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| Started | 56 | 112 | 18 |
| Completed | 0 | 0 | 0 |
| Not completed | 56 | 112 | 18 |
| Withdrew: Progressive disease | 32 | 53 | 7 |
| Withdrew: Other reasons | 4 | 7 | 6 |
| Withdrew: Withdrawal by subject | 8 | 23 | 0 |
| Withdrew: Lack of efficacy | 2 | 0 | 0 |
| Withdrew: Adverse event | 8 | 10 | 3 |
| Withdrew: Death | 2 | 4 | 0 |
| Withdrew: Transition to commercially available treatment | 0 | 4 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 10 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
ORR per Modified International Myeloma Working Group (mIMWG) Criteria is defined as the percentage of participants who achieve best overall response of Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours
| Percentage of participants | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| Overall Response Rate (ORR) | 32.1 | 79.5 | 94.4 |
PFS is defined as the time from the first dose to the first documentation of disease progression according to modified International Myeloma Working Group (mIMWG) criteria or death from any cause, whichever occurs first. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. Based on Kaplan-Meier Estimates.
| Months | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| Progression Free Survival (PFS) | 9.5 (6.2 to 15.2) | 26.4 (18.7 to 46.5) | NA (18.6 to NA) |
OS is defined as the time from start of treatment until the time of death from any cause. If no death is recorded the subject will be censored at the time the subject was last known to be alive. Based on Kaplan-Meier Estimates
| Months | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| Overall Survival (OS) | 38.2 (26.1 to 55.8) | 56.7 (43.6 to NA) | NA (26.2 to NA) |
DoR is defined as thr time from the initial documented response (partial response or better) to the first confirmed progressive disease or until death from any cause. Participants without documented progression will be censored at the time of their last response assessment. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours. Based on Kaplan-Meier Estimates
| Months | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| Duration of Response (DoR) | 30.2 (6.8 to NA) | 35.3 (22.4 to 52.5) | NA (26.3 to NA) |
TTR is defined as the time from the start of treatment to the first documented response (Partial Response, Very Good Partial Response or Complete Response) based on according to modified International Myeloma Working Group (mIMWG) criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR=≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours. Based on Kaplan-Meier Estimates
| Months | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| Time to Response (TTR) | 1.9 (0.9 to 12.8) | 1.0 (0.8 to 4.8) | 1.2 (1.0 to 9.0) |
TTP is defined as the time from start of treatment until Progressive Disease (as determined by the site investigator according to modified International Myeloma Working Group (mIMWG) criteria). Participants not experiencing a documented progression will be censored at the time of their last response assessment. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. Based on Kaplan-Meier Estimates
| Months | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| Time to Progression (TTP) | 12.2 (7.9 to 28.5) | 34.5 (23.5 to 57.7) | NA (18.6 to NA) |
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
| Participants | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| TEAE | 56 | 112 | 18 |
| TEAE related to Pomalidomide | 40 | 105 | 17 |
| TEAE related to Dexamethasone | 34 | 86 | 18 |
| TEAE related to Daratumumab | 0 | 90 | 18 |
| Metastatic Malignant Melanoma | 0 | 1 | 0 |
Collected over Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A | 31/56 (55.4%) | 30/56 (53.6%) | 56/56 (100%) |
| Cohort B | 51/112 (45.5%) | 69/112 (61.6%) | 112/112 (100%) |
| Cohort C | 8/18 (44.4%) | 11/18 (61.1%) | 18/18 (100%) |
| Event | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| CataractEye disorders | 0/56 | 0/112 | 4/18 |
| PneumoniaInfections and infestations | 8/56 | 18/112 | 4/18 |
| COVID-19Infections and infestations | 0/56 | 1/112 | 2/18 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/56 | 11/112 | 0/18 |
| PyrexiaGeneral disorders and administration site conditions | 4/56 | 2/112 | 1/18 |
| InfluenzaInfections and infestations | 4/56 | 3/112 | 0/18 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/56 | 7/112 | 0/18 |
| Cardiac failure chronicCardiac disorders | 0/56 | 0/112 | 1/18 |
| COVID-19 pneumoniaInfections and infestations | 0/56 | 1/112 | 1/18 |
| Cytomegalovirus infectionInfections and infestations | 0/56 | 0/112 | 1/18 |
| Event | Cohort A | Cohort B | Cohort C |
|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 13/56 | 75/112 | 14/18 |
| FatigueGeneral disorders and administration site conditions | 22/56 | 57/112 | 3/18 |
| DiarrhoeaGastrointestinal disorders | 15/56 | 48/112 | 3/18 |
| CoughRespiratory, thoracic and mediastinal disorders | 11/56 | 47/112 | 1/18 |
| CataractEye disorders | 5/56 | 15/112 | 7/18 |
| NauseaGastrointestinal disorders | 14/56 | 43/112 | 1/18 |
| AnaemiaBlood and lymphatic system disorders | 21/56 | 33/112 | 5/18 |
| Upper respiratory tract infectionInfections and infestations | 12/56 | 41/112 | 3/18 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 20/56 | 41/112 | 1/18 |
| LeukopeniaBlood and lymphatic system disorders | 0/56 | 12/112 | 6/18 |
| Age, Categorical(Participants) | Cohort A | Cohort B | Cohort C | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 50 | 6 | 77 |
| >=65 years | 35 | 62 | 12 | 109 |
| Sex: Female, Male(Participants) | Cohort A | Cohort B | Cohort C | Total |
|---|---|---|---|---|
| Female | 24 | 36 | 4 | 64 |
| Male | 32 | 76 | 14 | 122 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A | Cohort B | Cohort C | Total |
|---|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 0 | 9 |
| Not Hispanic or Latino | 50 | 109 | 18 | 177 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort A | Cohort B | Cohort C | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 4 | 6 | 18 | 28 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 3 | 10 | 0 | 13 |
| White | 47 | 91 | 0 | 138 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 5 | 0 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2014 to primary completion in Apr 2025, 131 months.
Results were first posted in May 2026, 1 year 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 131 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 May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pomalidomide · Dexamethasone