Multiple Myeloma Clinical Trial

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

Summary

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).

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

208

Study ID:

NCT04586426

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 40 Locations for this study

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University of Alabama at Birmingham, Comprehensive Cancer Center
Birmingham Alabama, 35233, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Emory University
Atlanta Georgia, 30322, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University in St. Louis
Saint Louis Missouri, 63130, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Atrium Health
Charlotte North Carolina, 28204, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Oregon Health And Science University
Portland Oregon, 97239, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
St. Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
Royal Perth Hospital
Perth , 6000, Australia
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Alberta Health Services
Edmonton Alberta, T6G 1, Canada
Princess Margaret Cancer Centre University Health Network
Toronto Ontario, M5G 1, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
Hadassah Medical Center
Jerusalem , 91120, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv , 64239, Israel
Kanazawa University Hospital
Kanazawa , 920-8, Japan
Nagoya City University Hospital
Nagoya , 467 8, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Tohoku University Hospital
Sendai shi , 980 8, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. Clinic de Barcelona
Barcelona , 08036, Spain
Inst. Cat. Doncologia-H Duran I Reynals
L Hospitalet De Llobregat , 08908, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
UNIV. HOSP. October 12
Madrid , 28041, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

208

Study ID:

NCT04586426

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

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