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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
Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B and Cohort C must agree to use a latex condom during any sexual contact with FCBP while participating in the study and until 3 months after last dose of daratumumab
Males must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment. Male subjects enrolled in Cohort B and Cohort C must also agree to refrain from donating semen or sperm during the treatment phase and until 3 months after last dose of daratumumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

POM MM 014 Trial 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.Check my eligibility
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.See study design
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.

POM MM 014 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use a condom during sexual activity while in the study and for some time after.
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I agree not to donate semen during and up to 3 months after treatment.
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I agree not to donate blood during and for 28 days after the study.
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I have had 2 previous treatments for my myeloma.
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I have had 1 or 2 treatments for my myeloma before.
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My myeloma has worsened despite my last treatment.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I have provided a bone marrow sample to check for specific blood cell changes.
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I agree to use two forms of birth control or abstain from sex, and undergo regular pregnancy tests if I join the study.
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I have been treated with LEN or a LEN-containing regimen for at least 2 cycles recently.
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I am an adult with MM and have measurable levels of M-protein in my blood or urine.

POM MM 014 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Adverse Events
Duration of Response (DoR)
Overall survival (OS)
+3 more

Side effects data

From 2015 Phase 2 trial • 36 Patients • NCT02011113
72%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
PYREXIA
25%
CONSTIPATION
25%
NASOPHARYNGITIS
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
DYSGEUSIA
14%
PNEUMONIA
11%
FATIGUE
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
11%
EPISTAXIS
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
RASH MACULO-PAPULAR
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
WEIGHT INCREASED
6%
CANCER PAIN
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
DECUBITUS ULCER
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
PERIPHERAL SENSORY NEUROPATHY
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
CYSTITIS
6%
GASTROENTERITIS
6%
DIABETES MELLITUS
6%
RESTLESSNESS
6%
INCREASED APPETITE
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
SEPSIS
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
MULTI-ORGAN FAILURE
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
3%
PNEUMONIA PNEUMOCOCCAL
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone

POM MM 014 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
~2590
Daratumumab
2014
Completed Phase 3
~1860

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
632 Previous Clinical Trials
127,734 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,677 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
1,499 Previous Clinical Trials
3,367,067 Total Patients Enrolled
71 Trials studying Multiple Myeloma
25,051 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01946477 — Phase 2
Multiple Myeloma Research Study Groups: Pomalidomide + Dexamethasone + Daratumumab, Pomalidomide + dexamethasone
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT01946477 — Phase 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01946477 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pomalidomide received official recognition from the FDA?

"While there is some evidence backing Pomalidomide's safety, as this is a Phase 2 trial, there is no clinical data supporting its efficacy. Consequently, it received a score of 2."

Answered by AI

Could you please list other research studies in which Pomalidomide has been used?

"Although first studied in 2002, there has been a proliferation of clinical trials involving pomalidomide since then. Out of the 1157 completed trials, 647 are active, many of which are based in Denver, Colorado."

Answered by AI

For what purpose is Pomalidomide most often prescribed?

"Pomalidomide is most often given to patients to help with ophthalmia, sympathetic. However, it can also be used as a form of treatment for branch retinal vein occlusion, macular edema, and communicable diseases."

Answered by AI

Are there any patients currently being accepted into the trial?

"As of right now, this particular clinical trial is no longer looking for new participants. It was first posted on May 29th, 2014 and was edited most recently on November 3rd, 2022. There are 826 trials actively enrolling patients with multiple myeloma and 647 studies for Pomalidomide that are currently accepting new patients."

Answered by AI
Recent research and studies
~18 spots leftby May 2025