Multiple Myeloma Clinical Trial

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

Summary

The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations.

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Full Description

Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Overall rationale of study is that daratumumab in combination with talquetamab or teclistamab may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. Daratumumab is human immunoglobulin G1 kappa monoclonal antibody (IgG1k) that binds with high affinity to a unique epitope on cluster of differentiation 38 (CD38) in a variety of hematological malignancies including multiple myeloma. Talquetamab and teclistamab are bispecific T cell redirection antibodies. Talquetamab binds to cluster of differentiation 3 (CD3) receptor complex on T cells and to G protein-coupled receptor family C group 5-member D (GPRC5D), a 7-transmembrane receptor protein on plasma cells and teclistamab binds to human and cynomolgus-CD3 and B cell maturation antigen (BCMA). Purpose of study is to evaluate safety of daratumumab in combination with talquetamab and teclistamab, and to evaluate preliminary antitumor activity of each combination. Study consists of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up period (after end of treatment and up to 16 weeks after last dose. End of study is defined as last study assessment for last participant in study. Total duration of study is approximately 2.4 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Participants safety will be monitored throughout study by Study Evaluation Team (SET). SET consists of members of sponsor's study team and participating investigators.

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Eligibility Criteria

Inclusion Criteria:

Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Must have either of the following: a) received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the treatment or b) disease that is double refractory to a PI and an IMiD
Measurable disease at screening as defined by any of the following: Serum monoclonal protein (M-protein) level >= 1.0 grams per deciliter (g/dL) (in non- immunoglobulin G (IgG) myeloma, an M-protein level >=0.5 g/dL); or Urine M-protein level >=200 milligram (mg)/24 hours; or Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and at Cycle 1, Day 1 predose
Women of childbearing potential must have a negative highly-sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (less than [<] 5 international units per milliliter [IU/mL]) at screening and a negative urine or serum pregnancy test within 1 day before the first dose of study drug

Exclusion Criteria:

Treatment in the prior 3 months with an anti- cluster of differentiation 38 (CD38) therapy (example, daratumumab), or discontinuation of a prior anti-CD38 therapy at any time due to an adverse event related to the anti-CD38 therapy
Live, attenuated vaccine within 4 weeks prior to the first dose of study drug unless approved by sponsor
Active Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded
Active hepatitis C infection as measured by positive hepatitis C virus- ribonucleotide (HCV)-RNA testing. Participants with a history of Hepatitis C virus antibody positivity must undergo HCV-RNA testing

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

296

Study ID:

NCT04108195

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 22 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
University of California, San Francisco
San Francisco California, 94143, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Vanderbilt - Ingram Cancer Center
Nashville Tennessee, 37212, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Universitatsklinikum Freiburg
Freiburg , 79106, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg , 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitätsklinikum Würzburg
Würzburg , 97080, Germany
VU Medisch Centrum
Amsterdam , 1081 , Netherlands
LUMC
Leiden , 2333Z, Netherlands
Hosp. Clinic I Provincial De Barcelona
Barcelona , 08036, Spain
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona , 08908, Spain
Germans Trias I Pujol
Barcelona , 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:

296

Study ID:

NCT04108195

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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