A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MonumenTAL-2)

A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Talquetamab; Drug: Carfilzomib; Drug: Daratumumab SC; Drug: Lenalidomide; Drug: Pomalidomide

• Study Type: Interventional
• Enrollment (Estimated): 182
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Australia
  • Fitzroy, Australia, 3065
    • Recruiting
    • St. Vincent's Hospital Melbourne
  • Melbourne, Australia, 3004
    • Recruiting
    • Alfred Health
  • Southport, Australia, 4215
    • Recruiting
    • Gold Coast University Hospital
  • Wollongong, Australia, 2500
    • Recruiting
    • Wollongong Hospital
• Belgium
  • Brussel, Belgium, 1200
    • Completed
    • Cliniques Universitaires St-Luc
  • Edegem, Belgium, 2650
    • Recruiting
    • UZA
  • Gent, Belgium, 9000
    • Recruiting
    • UZ Gent
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
• France
  • Nantes Cedex 1, France, 44093
    • Recruiting
    • CHU Nantes
  • Pessac cedex, France, 33604
    • Recruiting
    • CHU de Bordeaux - Hospital Haut-Leveque
  • Rennes, France, 35000
    • Recruiting
    • Chu Rennes Hopital Pontchaillou
  • TOULOUSE Cedex 9, France, 31059
    • Recruiting
    • Institut Universitaire du Cancer de Toulouse-Oncopole
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • UMCG
  • Maastricht, Netherlands, 6229 HX
    • Recruiting
    • Maastricht University Medical Centre
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • UMCU
• United Kingdom
  • London, United Kingdom, W1T 7HA
    • Recruiting
    • University College Hospital London
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie NHS Foundation Trust
  • Oxford, United Kingdom, OX3 7LE
    • Recruiting
    • Churchill Hospital
  • Surrey, United Kingdom, SM2 5PT
    • Recruiting
    • The Royal Marsden NHS Trust Sutton
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama Birmingham
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Colorado Blood Cancer Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical College
    • New York, New York, United States, 10029
      • Recruiting
      • Mt. Sinai School of Medicine
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Regimen A: Talquetamab + Carfilzomib; Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: JNJ-64407564; Drug: Carfilzomib; Carfilzomib will be administered as an IV infusion.
Experimental: Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib; Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: JNJ-64407564; Drug: Carfilzomib; Carfilzomib will be administered as an IV infusion.; Drug: Daratumumab SC; Daratumumab will be administered subcutaneously.
Experimental: Treatment Regimen C: Talquetamab + Lenalidomide; Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: JNJ-64407564; Drug: Lenalidomide; Lenalidomide will be self-administered orally.
Experimental: Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide; Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: JNJ-64407564; Drug: Daratumumab SC; Daratumumab will be administered subcutaneously.; Drug: Lenalidomide; Lenalidomide will be self-administered orally.
Experimental: Treatment Regimen E: Talquetamab + Pomalidomide; Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: JNJ-64407564; Drug: Pomalidomide; Pomalidomide will be self-administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria.	Up to 1 year and 10 months
Very Good Partial Response (VGPR) or Better Response Rate	VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR] + complete response [CR] +VGPR) according to the IMWG 2016 criteria.	Up to 1 year and 10 months
Complete Response (CR) or Better Response Rate	CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.	Up to 1 year and 10 months
Stringent Complete Response (sCR)	sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.	Up to 1 year and 10 months
Duration of Response	Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG 2016 criteria, or death due to disease progression, whichever occurs first.	Up to 1 year and 10 months
Time to Response	Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.	Up to 1 year and 10 months
Serum Concentration of Talquetamab	Serum samples will be analyzed to determine concentrations of talquetamab.	Up to 1 year and 10 months
Serum Concentration of Daratumumab	Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D.	Up to 1 year and 10 months
Number of Participants with Anti-Drug Antibodies to Talquetamab	Number of participants with anti-drug antibodies to talquetamab will be reported.	Up to 1 year and 10 months
Number of Participants with Anti-Drug Antibodies to Daratumumab	Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D.	Up to 1 year and 10 months
Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)	Number of participants with anti-drug antibodies to rHuPH20 will be reported.	Up to 1 year and 10 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2021
• Primary Completion (Estimated): July 2, 2025
• Study Completion (Estimated): August 5, 2025

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Pomalidomide; Lenalidomide; Daratumumab
• Other Study ID Numbers: CR108946; 2020-004502-55 (EudraCT Number); 64407564MMY1004 (Other Identifier: Janssen Research & Development, LLC); 2023-503620-60-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No