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Talquetamab for Multiple Myeloma

Phase 2
Recruiting
Led By Sham Mailankody, MBBS
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hepatic Function: AST and ALT ≤ 2.5 x upper limit of normal, Serum total bilirubin ≤ 2 x ULN, INR or PTT < 1.5 x ULN
Patient with multiple myeloma who has received prior treatment with an IMID, PI, and a CD38 monoclonal antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial tests if adding talquetamab to BCMA CAR T-cell therapy helps treat relapsed or refractory multiple myeloma. All participants have already received ide-cel.

Who is the study for?
This trial is for adults with multiple myeloma who've had BCMA CAR T-cell therapy. They must be in good health, not planning to have children soon, and able to follow the study plan. People can't join if they've had certain other treatments recently, are pregnant or breastfeeding, have serious infections or illnesses that could affect participation, or require high doses of steroids.Check my eligibility
What is being tested?
The study tests Talquetamab's effectiveness in patients with relapsed/refractory multiple myeloma post-BCMA CAR T-cell therapy ide-cel. It aims to determine if this drug can help after previous treatment with a specific cell therapy.See study design
What are the potential side effects?
While the side effects of Talquetamab aren't detailed here, similar cancer drugs may cause immune reactions, infusion-related symptoms like fever or chills, fatigue, blood count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver tests are within the required limits.
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I have multiple myeloma and have been treated with IMID, PI, and a CD38 antibody.
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I am fully active or can carry out light work.
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I don't have ongoing symptoms from immune therapy side effects.
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I haven't received any myeloma treatments after my CART cell therapy.
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My kidney function, measured by creatinine clearance, is adequate.
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My heart pumps well, with an ejection fraction of 45% or higher.
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I received ide-cel therapy 1-3 months ago.
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I am using approved birth control methods and agree to pregnancy tests.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Rate of sustained Minimal Residual Disease (MRD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: TalquetamabExperimental Treatment1 Intervention
Subcutaneous Talquetamab

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,881 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,150 Patients Enrolled for Multiple Myeloma
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
205,054 Total Patients Enrolled
11 Trials studying Multiple Myeloma
715 Patients Enrolled for Multiple Myeloma
Sham Mailankody, MBBSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
65 Total Patients Enrolled
4 Trials studying Multiple Myeloma
65 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there presently any open slots in this research study?

"This research project, which was initially posted on September 27th 2023 is now actively recruiting trial participants. The latest update to the data occurred on the same day as its initial post."

Answered by AI

Has Talquetamab been given the green light by the FDA?

"Assigned a rating of 2 due to its Phase 2 status, Talquetamab has some safety data but lacks evidence of efficacy."

Answered by AI

Are there multiple research centers conducting this clinical experiment in North America?

"Currently, 7 medical centres across the country are enrolling patients in this clinical trial. These sites can be found in Middletown, Montvale and Commack as well as other nearby cities; therefore, it is advisable to choose a location nearest to you for convenience's sake."

Answered by AI

What is the present number of participants involved in this clinical investigation?

"Affirmative. According to the information on clinicaltrials.gov, this medical study is currently enrolling patients and was initially posted on September 27th 2023. 17 individuals are required from 7 sites for completion of the trial."

Answered by AI
~11 spots leftby Oct 2026