Actively Recruiting
Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-03-25
88
Participants Needed
40
Research Sites
275 weeks
Total Duration
On this page
Sponsors
A
Alliance for Clinical Trials in Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.
CONDITIONS
Official Title
Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma with relapsed or refractory disease according to IMWG criteria
- Measurable disease by serum M-protein, urine monoclonal protein, or serum free light chains
- At least two prior therapy lines with exposure or resistance to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 antibodies
- No prior treatment with iberdomide, belantamab mafodotin, or BCMA-directed therapy
- Age 18 years or older
- ECOG performance status of 0 to 2
- Adequate blood counts and organ function including ANC 2000/mm3, platelets 75000/mm3 (or 50000/mm3 if bone marrow plasma cells > 50%), creatinine clearance 3 mL/min, bilirubin 2 mg/dL, and liver enzymes 2.5 times upper limit of normal
- Negative pregnancy test and use of effective contraception for women of childbearing potential and men during and after study as specified
- Archival tissue available for correlative studies
- Patients with prior or concurrent malignancies that do not interfere with study safety or efficacy
- Patients with treated brain metastases without progression
- HIV-positive patients on effective therapy with undetectable viral load within 6 months
You will not qualify if you...
- History of severe allergic reaction to lenalidomide, pomalidomide, or other IMiD drugs
- Prior allogeneic stem cell transplant except syngeneic without graft versus host disease
- Live or live-attenuated vaccine use within 30 days before registration
- Plasmapheresis within 7 days before registration
- Uncontrolled HIV, hepatitis B or C infection unless meeting specific controlled criteria
- Unacceptable cardiac risk factors including unstable arrhythmias, recent heart attack or acute coronary syndrome, severe heart failure, uncontrolled hypertension, congenital long QT syndrome, symptomatic bradycardia, or severely reduced heart function
- Recent use of targeted or investigational agents within 2 weeks before registration without recovery
- Recent major surgery within 2 weeks before registration without recovery
- Medical conditions preventing swallowing oral medications
- Active bacterial, viral, or fungal infections
- Liver disease with Child-Pugh score greater than 1
- Active renal disease requiring dialysis or other conditions affecting safety
- Active bleeding
- Hypersensitivity to belantamab mafodotin or related drugs
- Active amyloidosis, POEMS syndrome, or plasma cell leukemia
- Chronic use of strong CYP3A4 inhibitors or inducers without appropriate discontinuation
- Current corneal epithelial disease except mild changes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
2
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
3
McFarland Clinic - Boone
Boone, Iowa, United States, 50036
Suspended
4
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
5
McFarland Clinic - Jefferson
Jefferson, Iowa, United States, 50129
Suspended
6
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States, 50158
Actively Recruiting
7
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
8
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
10
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
11
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
12
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
13
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
14
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
15
OhioHealth O'Bleness Hospital
Athens, Ohio, United States, 45701
Actively Recruiting
16
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Actively Recruiting
17
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
18
Grant Medical Center
Columbus, Ohio, United States, 43215
Actively Recruiting
19
Doctors Hospital
Columbus, Ohio, United States, 43228
Actively Recruiting
20
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Actively Recruiting
21
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Actively Recruiting
22
Columbus Oncology and Hematology Associates
Dublin, Ohio, United States, 43016
Actively Recruiting
23
Dublin Methodist Hospital
Dublin, Ohio, United States, 43016
Actively Recruiting
24
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States, 44903
Actively Recruiting
25
OhioHealth Marion General Hospital
Marion, Ohio, United States, 43302
Actively Recruiting
26
OhioHealth Pickerington Methodist Hospital
Pickerington, Ohio, United States, 43147
Actively Recruiting
27
OhioHealth Westerville Medical Campus/Westerville Cancer Center
Westerville, Ohio, United States, 43082
Actively Recruiting
28
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
29
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
30
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
31
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
32
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Actively Recruiting
33
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
34
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Actively Recruiting
35
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Actively Recruiting
36
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
37
Sheboygan Physicians Group
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
38
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235-1495
Actively Recruiting
39
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
40
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
Research Team
M
Monique Hartley-Brown, MD
CONTACT
D
Destin Carlisle
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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