A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R\[s\]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).

Key facts

Study ID

NCT04586426

Run by

Janssen Research & Development, LLC

People needed

228

Starts

2020-12-15

Expected to finish

2026-10-27

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
• Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
• Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration

You may not qualify if…

• All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy
• All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment.
• All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma.
• All Parts: Active plasma cell leukemia (greater than [>]2.0*10\^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis

Where it is running

• University of Alabama at Birmingham, Comprehensive Cancer Center — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University St. Louis School Medicine Siteman Cancer Center — St Louis, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Atrium Health — Charlotte, North Carolina, United States
• Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health And Science University — Portland, Oregon, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• St Vincents Hospital Melbourne — Fitzroy, Australia
• Royal Perth Hospital — Perth, Australia
• Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
• Alberta Health Services — Edmonton, Alberta, Canada
• Princess Margaret Cancer Centre University Health Network — Toronto, Ontario, Canada
• McGill University Health Centre — Montreal, Quebec, Canada
• Hadassah Medical Center — Jerusalem, Israel
• Sheba Medical Center — Ramat Gan, Israel
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
• Kanazawa University Hospital — Kanazawa, Japan
• Nagoya City University Hospital — Nagoya, Japan
• Osaka University Hospital — Osaka, Japan

Full record on ClinicalTrials.gov

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