Multiple Myeloma Clinical Trial

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Summary

The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.

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Full Description

Multiple myeloma is a malignant plasma cell disorder that accounts for approximately 10 percent (%) of all hematologic cancers, making it the second most common hematologic malignancy. The overall rationale of this study is that talquetamab or teclistamab in combination with a PD-1 inhibitor may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study will evaluate the clinical hypothesis that talquetamab or teclistamab can be safely administered at the selected dose when combined with a PD-1 inhibitor. The study will consist of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up. End of study is defined as last study assessment for last participant in study. Total duration of study is up to 2 years 5 months. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit
Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level >= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months)
Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant
Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
Active Central Nervous System (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
Live, attenuated vaccine within 4 weeks before the first dose of study treatment
Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia [any grade] or peripheral neuropathy to Grade <= 2)
Received a cumulative dose of corticosteroids equivalent to >= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

152

Study ID:

NCT05338775

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 19 Locations for this study

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Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York New York, 10011, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Vanderbilt - Ingram Cancer Center
Nashville Tennessee, 37232, United States
CHU de Montpellier, Hopital Saint-Eloi
Montpellier Cedex 5 , 34295, France
CHU de Nantes hotel Dieu
Nantes Cedex 1 , 44093, France
CHU Poitiers - Hopital la Miletrie
Poitiers , 86021, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse Cedex 9 , 31059, France
Universitatsklinikum Carl Gustav Carus Dresden
Dresden , 01307, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg , 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitatsklinikum Wurzburg
Wuerzburg , 97080, Germany
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

152

Study ID:

NCT05338775

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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