A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

NCT04722146 | Active Not Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: CR10892764007957MMY10042020-004404-332023-503440-14-00
• Study Type: interventional
• Target: 140
• Locations: 5 countries
• Sites: 27

Brief Summary

The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Incidence of Adverse Events (AEs)

  An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.

  Up to 2 year and 5 months

• Number of Participants with AEs by Severity

  Number of participants with AEs by severity will be reported.

  Up to 2 year and 5 months

• Number of Participants with Abnormalities in Laboratory Values

  Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.

  Up to 2 year and 5 months

• Number of Participants with Dose-Limiting Toxicity (DLT)

  The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.

  Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)

Secondary Outcomes (12)

• Overall Response Rate (ORR)

  Up to 2 year and 5 months

• Very Good Partial Response (VGPR) or Better Response Rate

  Up to 2 year and 5 months

• Complete Response (CR) or Better Response Rate

  Up to 2 year and 5 months

• Stringent Complete Response (sCR) Rate

  Up to 2 year and 5 months

• Duration of Response

  Up to 2 year and 5 months

Study Arms (6)

Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide

EXPERIMENTAL

Participants will receive teclistamab plus daratumumab plus pomalidomide.

Drug: Teclistamab; Drug: Daratumumab; Drug: Pomalidomide

Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)

EXPERIMENTAL

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.

Drug: Teclistamab; Drug: Daratumumab; Drug: Lenalidomide; Drug: Bortezomib

Treatment Regimen C: Teclistamab + Nirogacestat

EXPERIMENTAL

Participants will receive teclistamab plus nirogacestat.

Drug: Teclistamab; Drug: Nirogacestat

Treatment Regimen D: Teclistamab + Lenalidomide

EXPERIMENTAL

Participants will receive teclistamab plus lenalidomide.

Drug: Teclistamab; Drug: Lenalidomide

Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide

EXPERIMENTAL

Participants will receive teclistamab plus daratumumab plus lenalidomide.

Drug: Teclistamab; Drug: Daratumumab; Drug: Lenalidomide

Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)

EXPERIMENTAL

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.

Drug: Teclistamab; Drug: Daratumumab; Drug: Lenalidomide; Drug: Bortezomib

Interventions

Pomalidomide DRUG

Participants will receive pomalidomide.

Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide

Nirogacestat DRUG

Participants will receive nirogacestat.

Treatment Regimen C: Teclistamab + Nirogacestat

Daratumumab DRUG

Participants will receive daratumumab.

Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide; Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles); Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide; Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)

Lenalidomide DRUG

Participants will receive lenalidomide.

Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles); Treatment Regimen D: Teclistamab + Lenalidomide; Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide; Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)

Bortezomib DRUG

Participants will receive bortezomib.

Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles); Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)

Teclistamab DRUG

Participants will receive teclistamab.

Also known as: JNJ-64007957

Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide; Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles); Treatment Regimen C: Teclistamab + Nirogacestat; Treatment Regimen D: Teclistamab + Lenalidomide; Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide; Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
• Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab \[tec\]-daratumumab \[dara\]-pomalidomide \[pom\]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide \[len\]-bortezomib \[bor\]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat \[niro\]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (\>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
• Have measurable disease at screening as defined by at least one of the following: serum M-protein level \>= 1.0 gram/deciliter (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 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
• A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[hCG\]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study treatment

You may not qualify if:

• Live, attenuated vaccine within 30 days before the first dose of study treatment
• Received a cumulative dose of corticosteroids equivalent to \>= 140 mg of prednisone within the 14-day period before the start of study treatment administration
• 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
• Known to be seropositive for human immunodeficiency virus

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (27)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Winship Cancer Institute Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110-1032, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

St Vincents Hospital Melbourne

Fitzroy, 3065, Australia

Location

Alfred Health

Melbourne, 3004, Australia

Location

Calvary Mater Newcastle Hospital

Waratah, 2298, Australia

Location

UZA

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, 33604, France

Location

Chu Rennes Hopital Pontchaillou

Rennes, 35000, France

Location

Institut Universitaire du cancer de Toulouse-Oncopole

Toulouse, 31059, France

Location

University College Hospital

London, NW1 2BU, United Kingdom

Location

The Christie Nhs Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

The Royal Marsden NHS Trust Sutton

Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; pomalidomide; Lenalidomide; Bortezomib; nirogacestat

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• Janssen Research and Development, LLC Clinical Trial

  Janssen Research and Development LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: March 12, 2021
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): October 5, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (5); GB (3); US (14); AU (3); BE (2)