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A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma (TRIMM-3)

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ClinicalTrials.gov Identifier: NCT05338775
Recruitment Status : Recruiting
First Posted : April 21, 2022
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE March 31, 2022
First Posted Date  ICMJE April 21, 2022
Last Update Posted Date March 27, 2024
Actual Study Start Date  ICMJE May 25, 2022
Estimated Primary Completion Date September 21, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2022)
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 2 years 5 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 Adverse Events (AEs) by Severity [ Time Frame: Up to 2 years 5 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. 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 adverse event.
  • Number of Participants with Abnormalities in Clinical Laboratory Assessments [ Time Frame: Up to 2 years 5 months ]
    Number of participants with abnormalities in clinical laboratory assessments (serum chemistry and hematology) will be reported.
  • Number of Participants with Dose-Limiting Toxicity (DLTs) [ Time Frame: Up to 2 years 5 months ]
    The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2022)
  • Overall Response Rate (ORR) [ Time Frame: Up to 2 years 5 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.
  • Very Good Partial Response (VGPR) or Better Response Rate [ Time Frame: Up to 2 years 5 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 2 years 5 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) Rate [ Time Frame: Up to 2 years 5 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 2 years 5 months ]
    Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 criteria or death due to any cause, whichever occurs first.
  • Time to Response [ Time Frame: Up to 2 years 5 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 Concentrations of Talquetamab [ Time Frame: Up to 2 years 5 months ]
    Serum samples will be analyzed to determine concentrations of Talquetamab using validated, specific, and sensitive immunoassay methods.
  • Serum Concentrations of Teclistamab [ Time Frame: Up to 2 years 5 months ]
    Serum samples will be analyzed to determine concentrations of Teclistamab using validated, specific, and sensitive immunoassay methods.
  • Serum Concentrations of PD-1 Inhibitor [ Time Frame: Up to 2 years 5 months ]
    Serum samples will be analyzed to determine concentrations of PD-1 inhibitor using validated, specific, and sensitive immunoassay methods.
  • Number of Participants with Anti-Talquetamab Antibodies [ Time Frame: Up to 2 years 5 months ]
    Number of participants with anti-talquetamab antibodies will be reported.
  • Number of Participants with Anti-Teclistamab Antibodies [ Time Frame: Up to 2 years 5 months ]
    Number of participants with anti-teclistamab antibodies will be reported.
  • Number of Participants with Anti-PD-1 Inhibitor Antibodies [ Time Frame: Up to 2 years 5 months ]
    Number of participants with anti-PD-1 inhibitor antibodies 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 and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
Official Title  ICMJE A Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination With Checkpoint Inhibition for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
Brief Summary The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.
Detailed Description Multiple myeloma is a malignant plasma cell disorder that accounts for approximately 10 percent (%) of all hematologic cancers, making it the second most common hematologic malignancy. The overall rationale of this study is that talquetamab or teclistamab in combination with a PD-1 inhibitor may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study will evaluate the clinical hypothesis that talquetamab or teclistamab can be safely administered at the selected dose when combined with a PD-1 inhibitor. The study will consist of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up. End of study is defined as last study assessment for last participant in study. Total duration of study is up to 2 years 5 months. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/ Refractory Multiple Myeloma
Intervention  ICMJE
  • Drug: Talquetamab
    Talquetamab will be administered as a subcutaneous (SC) injection.
  • Drug: Teclistamab
    Teclistamab will be administered as a SC injection.
  • Drug: PD-1 Inhibitor
    The PD-1 inhibitor will be administered as an intravenous injection.
Study Arms  ICMJE
  • Experimental: Part 1: Dose Escalation
    Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.
    Interventions:
    • Drug: Talquetamab
    • Drug: Teclistamab
    • Drug: PD-1 Inhibitor
  • Experimental: Part 2: Dose Expansion
    Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.
    Interventions:
    • Drug: Talquetamab
    • Drug: Teclistamab
    • Drug: PD-1 Inhibitor
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: April 20, 2022)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 28, 2025
Estimated Primary Completion Date September 21, 2024   (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
  • Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit
  • Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level >= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams/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

Exclusion Criteria:

  • Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months)
  • Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant
  • Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
  • 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
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia [any grade] or peripheral neuropathy to Grade <= 2)
  • Received a cumulative dose of corticosteroids equivalent to >= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration
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 France,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05338775
Other Study ID Numbers  ICMJE CR109168
2021-005073-22 ( EudraCT Number )
64407564MMY1005 ( Other Identifier: Janssen Research and Development, LLC )
2022-502681-24-00 ( Registry Identifier: EUCT number )
Has Data Monitoring Committee No
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 & 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 and Development, LLC Clinical Trial Janssen Research and Development LLC
PRS Account Janssen Research & Development, LLC
Verification Date March 2024

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