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

NCT05050097 | Active Not Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: CR10894664407564MMY10042020-004502-552023-503620-60-00
• Study Type: interventional
• Target: 166
• Locations: 6 countries
• Sites: 31

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  Up to 1 year and 10 months

• Number of Participants with AEs by Severity

  Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE.

  Up to 1 year and 10 months

• Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

  Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.

  Up to 1 year and 6 months

• Number of Participants with Dose Limiting Toxicity (DLT)

  Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity.

  Up to 49 days

Secondary Outcomes (11)

• Overall Response Rate (ORR)

  Up to 1 year and 10 months

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

  Up to 1 year and 10 months

• Complete Response (CR) or Better Response Rate

  Up to 1 year and 10 months

• Stringent Complete Response (sCR)

  Up to 1 year and 10 months

• Duration of Response

  Up to 1 year and 10 months

Study Arms (5)

Treatment Regimen A: Talquetamab + Carfilzomib

EXPERIMENTAL

Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.

Drug: Talquetamab; Drug: Carfilzomib

Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib

EXPERIMENTAL

Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.

Drug: Talquetamab; Drug: Carfilzomib; Drug: Daratumumab SC

Treatment Regimen C: Talquetamab + Lenalidomide

EXPERIMENTAL

Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.

Drug: Talquetamab; Drug: Lenalidomide

Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide

EXPERIMENTAL

Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.

Drug: Talquetamab; Drug: Daratumumab SC; Drug: Lenalidomide

Treatment Regimen E: Talquetamab + Pomalidomide

EXPERIMENTAL

Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.

Drug: Talquetamab; Drug: Pomalidomide

Interventions

Talquetamab DRUG

Talquetamab will be administered subcutaneously.

Also known as: JNJ-64407564

Treatment Regimen A: Talquetamab + Carfilzomib; Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib; Treatment Regimen C: Talquetamab + Lenalidomide; Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide; Treatment Regimen E: Talquetamab + Pomalidomide

Carfilzomib DRUG

Carfilzomib will be administered as an IV infusion.

Treatment Regimen A: Talquetamab + Carfilzomib; Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib

Daratumumab SC DRUG

Daratumumab will be administered subcutaneously.

Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib; Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide

Lenalidomide DRUG

Lenalidomide will be self-administered orally.

Treatment Regimen C: Talquetamab + Lenalidomide; Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide

Pomalidomide DRUG

Pomalidomide will be self-administered orally.

Treatment Regimen E: Talquetamab + Pomalidomide

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
• Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level \>= 200 milligrams (mg)/24 hours; or c. 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
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
• A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
• Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program

You may not qualify if:

• Live, attenuated vaccine within 4 weeks 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
• History of stroke or seizure within 6 months prior to the first dose of study treatment

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (31)

University of Alabama 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

Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029, 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

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

St Vincents Hospital Melbourne

Fitzroy, 3065, Australia

Location

Alfred Health

Melbourne, 3004, Australia

Location

Gold Coast University Hospital

Southport, 4215, Australia

Location

Wollongong Hospital

Wollongong, 2500, Australia

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

UZA

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

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

UMCG

Groningen, 9713 GZ, Netherlands

Location

Maastricht University Medical Centre

Maastricht, 6229 HX, Netherlands

Location

UMCU

Utrecht, 3584 CX, Netherlands

Location

University College Hospital London

London, W1T 7HA, United Kingdom

Location

The Christie Nhs Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

The Royal Marsden NHS Trust Sutton

Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

talquetamab; carfilzomib; Lenalidomide; pomalidomide

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: September 22, 2021
• Primary Completion: March 31, 2025
• Study Completion (Estimated): October 13, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

BE (4); AU (4); FR (4); GB (4); US (12); NL (3)