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

NCT ID: NCT04108195

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

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-21

Study Completion Date

2027-04-07

Brief Summary

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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.

Detailed Description

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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 with or without pomalidomide 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 with or without pomalidomide, 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), a Post-treatment Follow-up Period (after the last dose of study drug and will continue for up to 16 weeks for each subject), and a Long-term Extension Period. The study will end when one of the following occurs: 1) the study drug has received marketing authorization and, if regionally applicable, government reimbursement is available; 2) a long-term extension rollover study has commenced for participants who are still benefiting from study treatment as determined by their investigator; or 3) all participants have discontinued study treatment. Total duration of study is approximately 5 years and 6 months. 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.

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 be assigned to either a combination of 1) daratumumab plus teclistamab or 2) daratumumab plus talquetamab or 3) daratumumab plus talquetamab plus pomalidomide or 4) daratumumab plus teclistamab plus pomalidomide.

Group Type EXPERIMENTAL

Daratumumab

Intervention Type DRUG

Participants will receive daratumumab.

Talquetamab

Intervention Type DRUG

Participants will receive talquetamab.

Teclistamab

Intervention Type DRUG

Participants will receive teclistamab.

Pomalidomide

Intervention Type DRUG

Participants will receive pomalidomide.

Part 2: Dose Expansion

Participants will be treated with the RP2D(s) for selected treatment combinations determined in Part 1.

Group Type EXPERIMENTAL

Daratumumab

Intervention Type DRUG

Participants will receive daratumumab.

Talquetamab

Intervention Type DRUG

Participants will receive talquetamab.

Teclistamab

Intervention Type DRUG

Participants will receive teclistamab.

Pomalidomide

Intervention Type DRUG

Participants will receive pomalidomide.

Interventions

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Daratumumab

Participants will receive daratumumab.

Intervention Type DRUG

Talquetamab

Participants will receive talquetamab.

Intervention Type DRUG

Teclistamab

Participants will receive teclistamab.

Intervention Type DRUG

Pomalidomide

Participants will receive pomalidomide.

Intervention Type DRUG

Other Intervention Names

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JNJ-54767414, Darzalex 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
* 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 milligrams (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
* Female participants 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
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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City of Hope National Medical Center

Duarte, California, United States

Site Status

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

The Blavatnik Family Chelsea Medical Center at Mount Sinai

New York, New York, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status

University Health Network UHN Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Universitatsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status

Universitaetsklinikum Hamburg Eppendorf

Hamburg, , Germany

Site Status

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Universitatsklinikum Wurzburg

Würzburg, , Germany

Site Status

VU Medisch Centrum

Amsterdam, , Netherlands

Site Status

LUMC

Leiden, , Netherlands

Site Status

Hosp Clinic de Barcelona

Barcelona, , Spain

Site Status

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, , Spain

Site Status

Germans Trias I Pujol

Barcelona, , Spain

Site Status

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Site Status

Clinica Univ. de Navarra

Pamplona, , Spain

Site Status

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Site Status

Countries

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United States Canada Germany Netherlands Spain

References

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Chari A, van de Donk NWCJ, Dholaria B, Weisel KC, Mateos MV, Goldschmidt H, Martin TG, Morillo D, Reece D, Rodriguez-Otero P, Bhutani M, D'Souza A, Oriol A, Rosinol L, Bahlis NJ, Vishwamitra D, Skerget S, Verona RI, Bakshi KK, Kang L, Prior TJ, Vandenberk L, Tolbert J, Lee S, Smit D, Wasch R. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025 Sep 22:blood.2025029360. doi: 10.1182/blood.2025029360. Online ahead of print.

Reference Type DERIVED
PMID: 40983036 (View on PubMed)

Pillarisetti K, Powers G, Luistro L, Babich A, Baldwin E, Li Y, Zhang X, Mendonca M, Majewski N, Nanjunda R, Chin D, Packman K, Elsayed Y, Attar R, Gaudet F. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393.

Reference Type DERIVED
PMID: 32956453 (View on PubMed)

Other Identifiers

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64407564MMY1002

Identifier Type: OTHER

Identifier Source: secondary_id

2019-000330-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-503468-17-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108620

Identifier Type: -

Identifier Source: org_study_id