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

• ClinicalTrials.gov Identifier: NCT05050097
• Recruitment Status: Recruiting
• First Posted: September 20, 2021
• Last Update Posted: May 31, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Tracking Information

• First Submitted Date: September 10, 2021
• First Posted Date: September 20, 2021
• Last Update Posted Date: May 31, 2023
• Actual Study Start Date: September 22, 2021
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 10, 2021)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 1 year and 10 months ]
  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.
• Number of Participants with AEs by Severity [ Time Frame: Up to 1 year and 10 months ]
  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.
• Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters [ Time Frame: Up to 1 year and 6 months ]
  Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.
• Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 49 days ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 10, 2021)

• Overall Response Rate (ORR) [ Time Frame: Up to 1 year and 10 months ]
  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.
• Very Good Partial Response (VGPR) or Better Response Rate [ Time Frame: Up to 1 year and 10 months ]
  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.
• Complete Response (CR) or Better Response Rate [ Time Frame: Up to 1 year and 10 months ]
  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.
• Stringent Complete Response (sCR) [ Time Frame: Up to 1 year and 10 months ]
  sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.
• Duration of Response [ Time Frame: Up to 1 year and 10 months ]
  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.
• Time to Response [ Time Frame: Up to 1 year and 10 months ]
  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.
• Serum Concentration of Talquetamab [ Time Frame: Up to 1 year and 10 months ]
  Serum samples will be analyzed to determine concentrations of talquetamab.
• Serum Concentration of Daratumumab [ Time Frame: Up to 1 year and 10 months ]
  Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D.
• Number of Participants with Anti-Drug Antibodies to Talquetamab [ Time Frame: Up to 1 year and 10 months ]
  Number of participants with anti-drug antibodies to talquetamab will be reported.
• Number of Participants with Anti-Drug Antibodies to Daratumumab [ Time Frame: Up to 1 year and 10 months ]
  Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D.
• Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) [ Time Frame: Up to 1 year and 10 months ]
  Number of participants with anti-drug antibodies to rHuPH20 will be reported.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
• Official Title: A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma

Intervention

• Drug: Talquetamab
  Talquetamab will be administered subcutaneously.
  Other Name: JNJ-64407564
• Drug: Carfilzomib
  Carfilzomib will be administered as an IV infusion.
• Drug: Daratumumab SC
  Daratumumab will be administered subcutaneously.
• Drug: Lenalidomide
  Lenalidomide will be self-administered orally.
• Drug: Pomalidomide
  Pomalidomide will be self-administered orally.

Study Arms

• 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.
  Interventions:

  • Drug: Talquetamab
  • Drug: Carfilzomib
• 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.
  Interventions:

  • Drug: Talquetamab
  • Drug: Carfilzomib
  • Drug: Daratumumab SC
• Experimental: Treatment Regimen C: Talquetamab + Lenalidomide
  Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.
  Interventions:

  • Drug: Talquetamab
  • Drug: Lenalidomide
• 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.
  Interventions:

  • Drug: Talquetamab
  • Drug: Daratumumab SC
  • Drug: Lenalidomide
• Experimental: Treatment Regimen E: Talquetamab + Pomalidomide
  Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.
  Interventions:

  • Drug: Talquetamab
  • Drug: Pomalidomide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 2, 2023): 182
• Original Estimated Enrollment (submitted: September 10, 2021): 176
• Estimated Study Completion Date: August 5, 2025
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

• Listed Location Countries: Australia, Belgium, France, Netherlands, United Kingdom, United States

Administrative Information

• NCT Number: NCT05050097
• Other Study ID Numbers: CR108946; 2020-004502-55 ( EudraCT Number ); 64407564MMY1004 ( Other Identifier: Janssen Research & Development, LLC )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

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

• URL: https://www.janssen.com/clinical-trials/transparency

• Current Responsible Party: Janssen Research & Development, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Janssen Research & Development, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Janssen Research & Development, LLC
• Verification Date: May 2023