Clinical trial for Multiple Myeloma
Official title Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06348108
What this study is testing
What is Talquetamab?
Talquetamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as Anti-CD3/Anti-GPRC5D Bispecific Monoclonal Antibody JNJ-64407564, DuoBody Antibody JNJ-64407564.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the combination of talquetamab, iberdomide, and dexamethasone is safe and how much of each drug people can take.
- Who it's for
- You may be able to join if you have relapsed or refractory multiple myeloma and have tried other treatments.
- What's involved
- You will receive the three drugs and have regular check‑ups to monitor your health. The doctors will watch for side effects and adjust doses as needed.
- Time commitment
- The study lasts several months, with visits every few weeks to track your progress and any side effects.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female ≥ 18 years of age.
- 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.
- 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...
- Dose expansion cohort: RRMM patients will be lenalidomide refractory, TCE (exposed to IMiD, PI and CD38 antibody therapy (≥ 2 cycles or 2 months of...
- Serum M-protein ≥ 0.5 g/dL (dose escalation) and 1.0 g/dL (dose expansion cohorts)
You likely can't join if
- Has persistent clinically significant toxicities (grade ≥ 2; per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events...
- Has NCI CTCAE grade ≥ 3 peripheral neuropathy from any etiology or grade ≥ 2 peripheral neuropathy with pain.
- Has received treatment with cytotoxic (alkylators) within 3 weeks, biologic (IMiDs/PIs) within 2 weeks, targeted therapies (monoclonal antibodies)...
- Has had radiation therapy within 14 days of first dose of study therapy, unless less than 5% marrow exposure, then no limit.
- Has had any prior GPRC5D targeted bispecific antibody therapy or GPRC5D CAR-T therapy or has had previous treatment with Iber.
- Has any active or uncontrolled infection including any viral, bacterial or fungal infection
See the full eligibility criteria
Who can join
- Male or female ≥ 18 years of age.
- 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.
- 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)...
- 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.
- Serum M-protein ≥ 0.5 g/dL (dose escalation) and 1.0 g/dL (dose expansion cohorts)
- Urine M-protein ≥ 200 mg/24 hours
- Serum free light chain (FLC) assay: involved FLC assay ≥ 10 mg/dL (≥ 100 mg/L) AND an abnormal serum FLC ratio (\ 1.65).
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Calculated creatinine clearance \> 30 mL/min as assessed by the Cockcroft-Gault equation, Modification of Diet in Renal Disease (MDRD) equation (National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)...
- Serum bilirubin ≤ 1.5 mg/dL, excluding Gilbert's.
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × institutional upper limit normal (ULN).
- Total serum calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) (treatment of hypercalcemia is allowed and patients may enroll if hypercalcemia returns to WNL with standard treatment).
- Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L (myeloid growth factors must not have been administered within 7 days (14 days for extended 1/2-life products).
- Hemoglobin ≥ 8 g/dL (red blood cell transfusions permitted provided the anemia is disease-related).
- Platelet count ≥ 100 x 10\^9/L and no platelet transfusions during the 7 days before first dose (without transfusions).
- Must have at least 2 negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test result obtained prior to initiating therapy.
- Men and women of childbearing potential must agree to not donate sperm and eggs (ova and oocytes) throughout study therapy and for 3 months after the last treatment.
- Men and women agree to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for 3 months after the last treatment with study treatment.
- Women of childbearing potential must agree to 2 methods of reliable birth control simultaneously while receiving study treatment and until 100 days after last dose of study treatment: one highly effective form of...
- Males must agree to always use a latex or synthetic condom during any sexual contact with females of reproductive potential.
- All patients should be encouraged to be fully vaccinated prior to initiation of therapy including being up-to-date on vaccines against pneumococcus, yearly influenza, Coronavirus disease (COVID) booster(s), and any age...
- Has provided signed informed consent before initiation of any study-specific procedures or treatment.
- Must agree to, and be capable of, adhering to the study visit schedule and other protocol requirements, including follow-up for overall survival.
What rules you out
- 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...
- Has NCI CTCAE grade ≥ 3 peripheral neuropathy from any etiology or grade ≥ 2 peripheral neuropathy with pain.
- 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...
- Has had radiation therapy within 14 days of first dose of study therapy, unless less than 5% marrow exposure, then no limit.
- Has had any prior GPRC5D targeted bispecific antibody therapy or GPRC5D CAR-T therapy or has had previous treatment with Iber.
- 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)...
- 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...
- Is pregnant or breast feeding.
- Uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure
- Uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months before study entry
- Uncontrolled hypertension or clinically significant arrhythmias not controlled by medication.
- Has active POEMS (polyneuropathy, organomegaly, endocrinopathy/edema, monoclonal-protein, skin syndrome), amyloid light (AL) amyloidosis, primary plasma cell leukemia or active central nervous system (CNS) or...
- Has uncontrolled, clinically significant organ dysfunction that in the opinion of the investigator would put the patient at significant risk for toxicity from study therapy.
- Has recent major surgery within 4 weeks or significant gastrointestinal (GI) disease that would interfere with GI absorption of oral medications.
- Has a condition, including autoimmune disease, requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before study therapy...
- Has received treatment with allogeneic stem cell transplant within 6 months before the first dose of study treatment and if \> 6 months from allogeneic stem cell transplantation (alloSCT) must be off all...
- Uncontrolled epilepsy or new/recent seizure activity within 6 months of study entry.
- Live vaccine administered within 4 weeks prior to study therapy.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.