Actively Recruiting
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
Led by Andrew Yee, MD · Updated on 2025-10-07
43
Participants Needed
3
Research Sites
415 weeks
Total Duration
On this page
Sponsors
A
Andrew Yee, MD
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying the combination of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma. Relapsed and Refractory Multiple Myeloma is the condition of returned or previous treatment resistant Multiple Myeloma. This research study involves two study drugs and two standard of care drugs. * The names of the study drugs involved in this study are: * Carfilzomib * Daratumumab * The names of the standard of care drugs involved in this study are: * Dexamethasone * Pomalidomide
CONDITIONS
Official Title
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 80 years
- Diagnosis of multiple myeloma with serum monoclonal protein ≥ 0.5 g/dL or ≥ 200 mg in urine or serum free light chain ≥ 100 mg/L with abnormal ratio
- Previously treated relapsed and refractory multiple myeloma with at least one prior therapy including 2 cycles of lenalidomide and 2 cycles of proteasome inhibitor
- Disease progression on or within 60 days after last therapy
- Absolute neutrophil count ≥ 1000/µL (with some exceptions possible)
- Platelet count ≥ 50,000/µL and no platelet transfusion within 7 days
- Hemoglobin ≥ 8 g/dL (red blood cell transfusions allowed)
- Creatinine clearance ≥ 30 mL/min
- Adequate liver function: bilirubin < 2 mg/dL and AST/ALT < 2.5 times upper limit of normal
- Able to take daily acetylsalicylic acid or approved alternative anticoagulation
- Registered in and able to comply with Pomalyst REMS program
- Females of reproductive potential must adhere to pregnancy testing requirements
- Men sexually active with women of childbearing potential must use barrier contraception and not donate sperm during study and 3 months after
- Able to swallow pomalidomide capsules whole
You will not qualify if you...
- Chemotherapy or radiotherapy within 2 weeks prior to study or not recovered from adverse events of earlier treatment
- Receiving other investigational agents
- Last therapy was the combination of carfilzomib, pomalidomide, and dexamethasone (prior single use allowed)
- Use of high dose corticosteroids (low dose allowed for non-myeloma disorders)
- Pregnancy, lactation, or planned breastfeeding
- Prior malignancies other than multiple myeloma within 3 years unless approved
- Plasma cell leukemia, POEMS syndrome, or amyloidosis
- Positive for HIV, hepatitis B or C (with some exceptions)
- Peripheral neuropathy grade 2 or higher despite treatment
- Hypersensitivity to study drugs
- Allogeneic stem cell transplant within 12 months or active graft versus host disease
- Significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that may interfere with study
- Known moderate or severe COPD or asthma within 2 years
- Major surgery within 2 weeks before treatment
- Other medical, psychiatric, or social conditions that preclude participation or interpretation
- Toxicity from previous anticancer therapy not resolved to baseline except alopecia and peripheral neuropathy
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02155
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
A
Andrew J Yee, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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