Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Alfred Chung, MD
You may qualify if…
- ✓ 1. Male or female ≥ 18 years of age.
- ✓ 2. Has a prior history of (h/o) MM (based on International Myeloma Working Group (IMWG) criteria) and now has evidence of relapsed or refractory MM. RRMM of progressive disease as defined by the IMWG 2006 and 2016 criteria (Kumar at al).
- ✓ 3. Specific criteria for dose escalation and dose expansion:
- ✓ 1. Phase 1 dose escalation: patients will be required to have TCE RRMM (including a proteasome inhibitor (PI) (≥ 2 cycles or 2 months of treatment), an immunomodulatory drug (IMiD)) (≥ 2 cycles or 2 months of treatment) and a CD38 antibody (≥ 2 cycles or 2 months of treatment) after receiving ≥ 3 prior lines of therapy. Prior BCMA exposure is allowed. (Subjects with discontinued PI/IMiD/Cluster of differentiation 38 (CD38) therapy due to severe adverse event after \< 2 months are allowed)
- ✓ 2. Dose expansion cohort: RRMM patients will be lenalidomide refractory, TCE (exposed to IMiD, PI and CD38 antibody therapy (≥ 2 cycles or 2 months of treatment for each) and have received ≥ 2 prior lines of therapy. Prior BCMA targeted therapy is allowed, not required. (Subjects with discontinued PI/IMiD/CD38 therapy due to severe adverse event after \< 2 months are allowed. Lenalidomide refractory is defined as having evidence of progressive disease on lenalidomide (≥ 10 mg or greater, ≥ 21 days/28) or within 60 days of stopping lenalidomide therapy.)
- ✓ 4. Has measurable disease defined as at least 1 of the following:
- ✓ 1. Serum M-protein ≥ 0.5 g/dL (dose escalation) and 1.0 g/dL (dose expansion cohorts)
- ✓ 2. Urine M-protein ≥ 200 mg/24 hours
You may not qualify if…
- ✕ 1. Has persistent clinically significant toxicities (grade ≥ 2; per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) from previous anticancer therapy (excluding alopecia which is permitted and excluding grades 2 and 3 laboratory abnormalities (including hematologic abnormalities) if participants are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies.
- ✕ 2. Has NCI CTCAE grade ≥ 3 peripheral neuropathy from any etiology or grade ≥ 2 peripheral neuropathy with pain.
- ✕ 3. Has received treatment with cytotoxic (alkylators) within 3 weeks, biologic (IMiDs/PIs) within 2 weeks, targeted therapies (monoclonal antibodies) within 4 weeks, chimeric antigen receptor (CAR) T-cell (CAR-T)or autologous stem cell transplant therapy within 3 months or any novel therapy within 5- 1/2 lives of therapy.
- ✕ 4. Has had radiation therapy within 14 days of first dose of study therapy, unless less than 5% marrow exposure, then no limit.
- ✕ 5. Has had any prior GPRC5D targeted bispecific antibody therapy or GPRC5D CAR-T therapy or has had previous treatment with Iber.
- ✕ 6. Has any active or uncontrolled infection including any viral, bacterial or fungal infection; and/or HIV, active hepatitis (Hep) C and active Hep B (hepatitis B (HB) surface antigen (HBsAg) (+), HB core antigen (HBcAb) (+) or (+) Hep B deoxyribonucleic acid (DNA) by polymerase chain reaction (pcr), Hep C ribonucleic acid (RNA) (+) by pcr. Patients who have received Intravenous immunoglobulin therapy (IVIG) replacement therapy may have (+) HBcAb results from the IVIG therapy. These patients can enroll if Hep B DNA by pcr test is negative. These patients need to be on antiviral therapy and be monitored for hepatitis B virus (HBV) DNA throughout study therapy per local guidelines and as clinically indicated.
- ✕ 7. Has an additional active malignancy that may confound the assessment of the study endpoints. If the patient has a past cancer history (active malignancy within 2 years before study entry) with substantial potential for recurrence, this must be discussed with the sponsor/investigator before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: nonmelanoma skin cancer and carcinoma in situ (including transitional cell carcinoma, cervical cancer, anal carcinoma, ductal carcinoma in situ (DCIS) and melanoma in situ), any cancer resected with curative intent, low-grade cancer not requiring therapy.
- ✕ 8. Is pregnant or breast feeding.
Where it's recruiting
San Francisco
Source: ClinicalTrials.gov · NCT06348108 · last updated 2026-03-13