Actively Recruiting
Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
Led by Alfred Chung, MD · Updated on 2026-03-13
32
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
A
Alfred Chung, MD
Lead Sponsor
J
Janssen Research & Development, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial will evaluate the safety, side effects, and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma (RRMM) who are triple class refractory and have been exposed to B-cell maturation antibody (BCMA) targeted therapy. These patients currently have limited treatment options and poor survival. Talquetamab is an FDA approved drug that can bring T-cells to the myeloma cell, resulting in myeloma cell death. Iberdomide is an investigational drug and works by targeting and destroying proteins that help myeloma cancer cells to survive. Dexamethasone is a corticosteroid, is similar to a natural hormone produced by the adrenal glands to reduce inflammation (swelling, heat, redness, and pain) and is used to in helping to treat certain types of cancer including myeloma.
CONDITIONS
Official Title
Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Prior history of multiple myeloma with evidence of relapsed or refractory disease
- For dose escalation: triple class exposed RRMM with at least 3 prior lines of therapy including proteasome inhibitor, immunomodulatory drug, and CD38 antibody; prior BCMA exposure allowed
- For dose expansion: lenalidomide refractory, triple class exposed RRMM with at least 2 prior lines of therapy; prior BCMA therapy allowed
- Measurable disease defined by serum or urine M-protein or serum free light chain assay
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function including creatinine clearance > 30 mL/min, serum bilirubin ≤ 1.5 mg/dL, AST and ALT ≤ 2.5 times upper limit normal, and normal calcium levels
- Adequate hematologic function with specified neutrophil, hemoglobin, and platelet counts
- Negative pregnancy tests prior to therapy for females of childbearing potential
- Agreement to use contraception and not donate sperm or eggs during and 3 months after treatment
- Fully vaccinated prior to therapy including pneumococcus, influenza, COVID booster, and age-appropriate vaccines
- Signed informed consent and ability to comply with study requirements
You will not qualify if you...
- Persistent clinically significant toxicities from prior cancer therapy (excluding alopecia and manageable lab abnormalities)
- Grade 3 or higher peripheral neuropathy or grade 2 peripheral neuropathy with pain
- Recent treatment with cytotoxic, biologic, targeted therapies, CAR-T, stem cell transplant, or novel therapies within specified time frames
- Radiation therapy within 14 days of first dose unless marrow exposure less than 5%
- Prior GPRC5D targeted bispecific antibody therapy, GPRC5D CAR-T, or iberdomide treatment
- Active or uncontrolled infections including viral, bacterial, fungal, HIV, active hepatitis B or C
- Additional active malignancies that could affect study assessment, except certain low-risk cancers
- Pregnancy or breastfeeding
- Significant cardiovascular disease including uncontrolled heart failure, angina, recent myocardial infarction, or uncontrolled arrhythmias
- Active POEMS syndrome, amyloid light chain amyloidosis, primary plasma cell leukemia, or active CNS myeloma
- Uncontrolled organ dysfunction posing risk for treatment toxicity
- Recent major surgery or significant gastrointestinal disease affecting oral drug absorption
- Conditions requiring systemic corticosteroids or immunosuppressants above specified doses within 14 days prior to treatment
- Allogeneic stem cell transplant within 6 months or ongoing graft-versus-host disease
- Uncontrolled epilepsy or seizure activity within 6 months
- Live vaccine administration within 4 weeks prior to study therapy start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Calfornia, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
U
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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