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

NCT ID: NCT04586426

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2026-10-27

Brief Summary

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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).

Detailed Description

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Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig) or fragments of such, which have subsequently lost their normal function. Rationale for combining talquetamab and teclistamab is the targeting of multiple proteins on the surface of multiple myeloma cells resulting in cell lysis. This study consists of 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment \[EOT\] visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s) for each participant). End of study is defined as 2 years after the last participant has received his or her initial dose of the treatment combination. Total duration of study is Approximately 5 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Dose Escalation

Participants will receive tec+tal with or without daratumumab in 28-day cycles following initial step-up doses.

Group Type EXPERIMENTAL

Talquetamab

Intervention Type DRUG

Talquetamab will be administered by subcutaneous (SC) injection.

Teclistamab

Intervention Type DRUG

Teclistamab will be administered by SC injection.

Daratumumab

Intervention Type DRUG

Daratumumab will be administered by SC injection.

Part 2: Dose Expansion

Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the recommended Phase 2 regimen (s) (RP2R\[s\]) of the study treatment identified in Part 1.

Group Type EXPERIMENTAL

Talquetamab

Intervention Type DRUG

Talquetamab will be administered by subcutaneous (SC) injection.

Teclistamab

Intervention Type DRUG

Teclistamab will be administered by SC injection.

Daratumumab

Intervention Type DRUG

Daratumumab will be administered by SC injection.

Part 3: Phase 2

Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2.

Group Type EXPERIMENTAL

Talquetamab

Intervention Type DRUG

Talquetamab will be administered by subcutaneous (SC) injection.

Teclistamab

Intervention Type DRUG

Teclistamab will be administered by SC injection.

Interventions

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Talquetamab

Talquetamab will be administered by subcutaneous (SC) injection.

Intervention Type DRUG

Teclistamab

Teclistamab will be administered by SC injection.

Intervention Type DRUG

Daratumumab

Daratumumab will be administered by SC injection.

Intervention Type DRUG

Other Intervention Names

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JNJ-64407564 JNJ-64007957

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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University of Alabama at Birmingham, Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Washington University St. Louis School Medicine Siteman Cancer Center

St Louis, Missouri, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Atrium Health

Charlotte, North Carolina, United States

Site Status

Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Oregon Health And Science University

Portland, Oregon, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

St Vincents Hospital Melbourne

Fitzroy, , Australia

Site Status

Royal Perth Hospital

Perth, , Australia

Site Status

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status

Alberta Health Services

Edmonton, Alberta, Canada

Site Status

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada

Site Status

McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Kanazawa University Hospital

Kanazawa, , Japan

Site Status

Nagoya City University Hospital

Nagoya, , Japan

Site Status

Osaka University Hospital

Osaka, , Japan

Site Status

Tohoku University Hospital

Sendai, , Japan

Site Status

Japanese Red Cross Medical Center

Shibuya City, , Japan

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul St Marys Hospital

Seoul, , South Korea

Site Status

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Site Status

Hosp Clinic de Barcelona

Barcelona, , Spain

Site Status

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, , Spain

Site Status

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Site Status

UNIV. HOSP. October 12

Madrid, , Spain

Site Status

Clinica Univ. de Navarra

Pamplona, , Spain

Site Status

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Site Status

Hosp. Univ. Marques de Valdecilla

Santander, , Spain

Site Status

Countries

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United States Australia Canada Israel Japan South Korea Spain

References

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Cohen YC, Magen H, Gatt M, Sebag M, Kim K, Min CK, Ocio EM, Yoon SS, Chu MP, Rodriguez-Otero P, Avivi I, Quijano Carde NA, Kumar A, Krevvata M, Peterson MR, Di Scala L, Scott E, Hilder B, Vanak J, Banerjee A, Oriol A, Morillo D, Mateos MV; RedirecTT-1 Investigators and Study Group. Talquetamab plus Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2025 Jan 9;392(2):138-149. doi: 10.1056/NEJMoa2406536.

Reference Type DERIVED
PMID: 39778168 (View on PubMed)

St Martin Y, Franz JK, Agha ME, Lazarus HM. Failure of CAR-T cell therapy in relapsed and refractory large cell lymphoma and multiple myeloma: An urgent unmet need. Blood Rev. 2023 Jul;60:101095. doi: 10.1016/j.blre.2023.101095. Epub 2023 Apr 29.

Reference Type DERIVED
PMID: 37173224 (View on PubMed)

Other Identifiers

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64007957MMY1003

Identifier Type: OTHER

Identifier Source: secondary_id

2019-004124-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-503439-16-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108901

Identifier Type: -

Identifier Source: org_study_id