Your session is about to expire
← Back to Search
Monoclonal Antibodies
Pomalidomide + Dexamethasone +/- Daratumumab for Multiple Myeloma (POM MM 014 Trial)
Phase 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects enrolling in Cohort A (POM+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy
Subjects enrolling in Cohort B and Cohort C (POM+DARA+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy
Must not have
Congestive heart failure (NY Heart Association Class III or IV)
Unstable or poorly controlled angina pectoris, including Prinzmetal's variant angina pectoris
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate the efficacy of pomalidomide and low-dose dexamethasone or the combination of pomalidomide, daratumumab, and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma.
Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who have previously been treated with lenalidomide. Participants must have measurable disease, acceptable organ and marrow function, and an ECOG score of 0-2. Women must avoid pregnancy and breastfeeding; men must use contraception. Exclusions include severe renal impairment, recent other treatments, certain infections like HIV/hepatitis, heart conditions, allergies to study drugs or their components.
What is being tested?
The trial tests the effectiveness of pomalidomide with low-dose dexamethasone (Cohort A), or this combination plus daratumumab (Cohorts B & C). Cohort A aims for a >30% response rate in patients previously treated with lenalidomide. Cohorts B & C target >70% and >60% response rates respectively; Cohort C includes only Japanese patients.
What are the potential side effects?
Potential side effects may include blood clots, lowered blood counts leading to increased infection risk or bleeding problems, fatigue, calcium level changes affecting bones/teeth/kidneys/heart/nerves/muscles digestion issues such as constipation or diarrhea; allergic reactions are possible due to drug sensitivities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had 2 previous treatments for my myeloma.
Select...
I have had 1 or 2 treatments for my myeloma before.
Select...
My myeloma has worsened despite my last treatment.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I have provided a bone marrow sample to check for specific blood cell changes.
Select...
I have been treated with LEN or a LEN-containing regimen for at least 2 cycles recently.
Select...
I am an adult with MM and have measurable levels of M-protein in my blood or urine.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe heart failure.
Select...
I do not have unstable or poorly controlled chest pain.
Select...
I have been treated with pomalidomide or daratumumab before.
Select...
I am currently using medication to treat myeloma.
Select...
I cannot or do not want to take blood clot prevention medication.
Select...
I have HIV or active/chronic hepatitis A, B, or C.
Select...
I need dialysis due to severe kidney problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate (ORR)
Secondary study objectives
Adverse Events
Duration of Response (DoR)
Overall survival (OS)
+3 moreSide effects data
From 2015 Phase 2 trial • 36 Patients • NCT0201111372%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
NASOPHARYNGITIS
25%
PYREXIA
25%
CONSTIPATION
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
PNEUMONIA
14%
DYSGEUSIA
11%
FATIGUE
11%
EPISTAXIS
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
8%
RASH MACULO-PAPULAR
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
CANCER PAIN
6%
DECUBITUS ULCER
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
CYSTITIS
6%
DIABETES MELLITUS
6%
GASTROENTERITIS
6%
RESTLESSNESS
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
WEIGHT INCREASED
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
SEPSIS
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pomalidomide + dexamethasoneExperimental Treatment2 Interventions
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.
Group II: Pomalidomide + Dexamethasone + DaratumumabExperimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2650
Daratumumab
2014
Completed Phase 3
~2000
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,246 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,620 Patients Enrolled for Multiple Myeloma
Amit Agarwal, MDStudy DirectorCelgene Corporation
1 Previous Clinical Trials
1 Trials studying Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,569 Previous Clinical Trials
3,384,178 Total Patients Enrolled
76 Trials studying Multiple Myeloma
28,918 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count is too low, depending on the percentage of a certain type of cells in your bone marrow.You are allergic to mannitol, corticosteroids, monoclonal antibodies, human proteins, or mammalian-derived products.I have severe heart failure.I do not have unstable or poorly controlled chest pain.Your blood calcium levels are higher than 11.5 mg/dL.I have been treated with pomalidomide or daratumumab before.I am currently using medication to treat myeloma.I do not have a stomach or bowel condition that affects how my body absorbs medication.I cannot or do not want to take blood clot prevention medication.My hemoglobin level is below 8 g/dL, but I may have had a blood transfusion or used erythropoietin.I agree to use a condom during sexual activity while in the study and for some time after.I agree not to donate semen during and up to 3 months after treatment.I agree not to donate blood during and for 28 days after the study.I have had 2 previous treatments for my myeloma.I have had 1 or 2 treatments for my myeloma before.My myeloma has worsened despite my last treatment.I can take care of myself and am up and about more than 50% of my waking hours.I have provided a bone marrow sample to check for specific blood cell changes.I agree to use two forms of birth control or abstain from sex, and undergo regular pregnancy tests if I join the study.I had a bone marrow or stem cell transplant less than a year ago and am still on immunosuppressants.I have HIV or active/chronic hepatitis A, B, or C.I have had hepatitis C but with no detectable virus for 6 months.I need dialysis due to severe kidney problems.I have not had a heart attack in the last 12 months.Your body has very low levels of a type of white blood cell called neutrophils.Your liver enzymes are more than three times the normal level.I have been treated with LEN or a LEN-containing regimen for at least 2 cycles recently.I have not had major surgery recently, except for kyphoplasty.You are allergic to thalidomide, LEN, or dex, or have had a severe rash from taking thalidomide or LEN before.I am an adult with MM and have measurable levels of M-protein in my blood or urine.Your blood test shows high levels of bilirubin, which may be a sign of liver problems.
Research Study Groups:
This trial has the following groups:- Group 1: Pomalidomide + dexamethasone
- Group 2: Pomalidomide + Dexamethasone + Daratumumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger