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).
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.
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
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There are 40 Locations for this study
Birmingham Alabama, 35233, United States
Little Rock Arkansas, 72205, United States
Denver Colorado, 80218, United States
Atlanta Georgia, 30322, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63130, United States
New York New York, 10029, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Houston Texas, 77030, United States
Fitzroy , 3065, Australia
Perth , 6000, Australia
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H4A 3, Canada
Jerusalem , 91120, Israel
Ramat Gan , 52621, Israel
Tel-Aviv , 64239, Israel
Kanazawa , 920-8, Japan
Nagoya , 467 8, Japan
Osaka , 565-0, Japan
Sendai shi , 980 8, Japan
Shibuya , 150-8, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Badalona , 08916, Spain
Barcelona , 08036, Spain
L Hospitalet De Llobregat , 08908, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
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