Actively Recruiting
A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-04
17
Participants Needed
7
Research Sites
209 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
J
Janssen Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The researchers are doing this study to find out whether talquetamab is an effective treatment after BCMA CAR Tcell therapy for people with relapsed or refractory multiple myeloma. All participants in this study will have already received the BCMA CAR T-cell therapy ide-cel for their disease.
CONDITIONS
Official Title
A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma and prior treatment with an IMID, PI, and a CD38 monoclonal antibody
- Received FDA-approved BCMA CAR T-cell therapy ide-cel within 1-3 months before enrollment
- Serum monoclonal protein less than 0.5 gm/dL; 24-hour urine monoclonal protein less than 200 mg; and serum involved free light chains less than 10 mg/dL
- No signs of disease progression based on IMWG criteria
- Age 18 years or older at consent
- ECOG performance status of 0 or 1
- Recovery to Grade 1 or baseline for non-blood toxicities from prior treatments (except Grade 2 neuropathy or alopecia)
- No ongoing cytokine release syndrome or immune neurotoxicity
- No additional myeloma treatments since CAR T-cell therapy
- Absolute neutrophil count at least 1,000/mm3 without recent growth factor support
- Platelet count at least 75,000/mm3 without recent transfusion or treatment; 50,000/mm3 acceptable if prior counts were lower
- Hemoglobin at least 8 g/dL without recent transfusion or erythropoietin
- Kidney function with creatinine clearance or eGFR at least 30 mL/min
- Oxygen saturation at least 92% on room air
- Liver function within specified limits for AST, ALT, and bilirubin
- Normal blood clotting times (INR or PTT less than 1.5 x ULN)
- Heart function with ejection fraction at least 45%
- Willing and able to follow study visits and protocol
- For women of childbearing potential: negative pregnancy tests and agreement to use effective contraception and avoid egg donation and breastfeeding during and after the study
- For men: agreement to use condoms and avoid sperm donation during and after the study
- Signed informed consent
You will not qualify if you...
- Prior or recent use of GRPRC5D-directed therapy, T-cell redirection therapy within 3 months, investigational vaccines (except approved COVID vaccines) within 4 weeks, live vaccines within 4 weeks
- Recent monoclonal antibody therapy (except COVID antibodies) within 21 days
- Recent cytotoxic, PI, IMiD therapies, radiotherapy, major surgery, or plasmapheresis within specified time frames
- Allogeneic stem cell transplant within 6 months or autologous transplant within 12 weeks before treatment
- High-dose corticosteroid use within 14 days
- Prior organ transplant requiring immunosuppressants
- Recent significant bleeding or ongoing anticoagulant treatment without approval
- Significant central nervous system diseases or involvement by multiple myeloma
- Other concurrent blood cancers or serious amyloidosis
- Severe heart failure or unstable heart conditions within 6 months
- Active autoimmune diseases needing immunosuppression (except some mild conditions)
- Positive tests for HIV, active hepatitis B or C infections
- Certain prior or active cancers unless approved by investigator
- Breastfeeding or intending pregnancy during study and 100 days after
- Planning to father a child during study and 100 days after
- Allergies to study medications
- Serious medical or psychiatric conditions interfering with study
- Uncontrolled infections
- Acute lung disease needing oxygen
- Unwilling or unable to consent or follow-up
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
S
Sham Mailankody, MBBS
CONTACT
S
Saad Usmani, MD, MBA
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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