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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05050097
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE September 10, 2021
First Posted Date  ICMJE September 20, 2021
Last Update Posted Date January 18, 2023
Actual Study Start Date  ICMJE September 22, 2021
Estimated Primary Completion Date August 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2021)
176
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 5, 2025
Estimated Primary Completion Date August 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com
Listed Location Countries  ICMJE Australia,   Belgium,   France,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05050097
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Janssen Research & Development, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP