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A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-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: NCT04722146
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE January 20, 2021
First Posted Date  ICMJE January 25, 2021
Last Update Posted Date September 9, 2022
Actual Study Start Date  ICMJE March 12, 2021
Estimated Primary Completion Date May 19, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2022)
  • Number of Participants with Incidence of Adverse Events (AEs) [ Time Frame: Up to 2 year and 5 months ]
    An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
  • Number of Participants with AEs by Severity [ Time Frame: Up to 2 year and 5 months ]
    Number of participants with AEs by severity will be reported.
  • Number of Participants with Abnormalities in Laboratory Values [ Time Frame: Up to 2 year and 5 months ]
    Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
  • Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B) ]
    The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2021)
  • Number of Participants with Incidence of Adverse Events (AEs) [ Time Frame: Up to 53 weeks ]
    An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
  • Number of Participants with AEs by Severity [ Time Frame: Up to 53 weeks ]
    Number of participants with AEs by severity will be reported.
  • Number of Participants with Abnormalities in Laboratory Values [ Time Frame: Up to 53 weeks ]
    Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
  • Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to Cycle 2 Day 15 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B) ]
    The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2022)
  • Overall Response Rate (ORR) [ Time Frame: Up to 2 year and 5 months ]
    ORR is defined as the proportion 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 year and 5 months ]
    VGPR or better response rate is defined as the proportion 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 year and 5 months ]
    CR or better response rate is defined as the proportion 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 year and 5 months ]
    sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.
  • Duration of Response [ Time Frame: Up to 2 year and 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 criteria.
  • Time to Response [ Time Frame: Up to 2 year and 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 Teclistamab [ Time Frame: Up to 2 year and 5 months ]
    Serum concentrations of teclistamab will be reported.
  • Serum Concentrations of Daratumumab [ Time Frame: Up to 2 year and 5 months ]
    Serum concentrations of daratumumab will be reported.
  • Serum Concentrations of Nirogacestat [ Time Frame: Up to 2 year and 5 months ]
    Serum concentration of nirogacestat will be reported.
  • Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab [ Time Frame: Up to 2 year and 5 months ]
    Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.
  • Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab [ Time Frame: Up to 2 year and 5 months ]
    Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F.
  • Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) [ Time Frame: Up to 2 year and 5 months ]
    Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2021)
  • Overall Response Rate (ORR) [ Time Frame: Up to 53 weeks ]
    ORR is defined as the proportion 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 53 weeks ]
    VGPR or better response rate is defined as the proportion 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 53 weeks ]
    CR or better response rate is defined as the proportion 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 53 weeks ]
    sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.
  • Duration of Response [ Time Frame: Up to 53 weeks ]
    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 criteria.
  • Time to Response [ Time Frame: Up to 53 weeks ]
    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 Teclistamab [ Time Frame: Up to 53 weeks ]
    Serum concentrations of teclistamab will be reported.
  • Serum Concentrations of Daratumumab [ Time Frame: Up to 53 weeks ]
    Serum concentrations of daratumumab will be reported.
  • Serum Concentrations of Nirogacestat [ Time Frame: Up to 53 weeks ]
    Serum concentration of nirogacestat will be reported.
  • Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab [ Time Frame: Up to 53 weeks ]
    Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.
  • Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab [ Time Frame: Up to 53 weeks ]
    Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A and Treatment Regimen B.
  • Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) [ Time Frame: Up to 53 weeks ]
    Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A and Treatment Regimen B.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Official Title  ICMJE A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Brief Summary The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.
Detailed Description Not Provided
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 Multiple Myeloma
Intervention  ICMJE
  • Drug: Teclistamab
    Participants will receive teclistamab.
    Other Name: JNJ-64007957
  • Drug: Daratumumab
    Participants will receive daratumumab.
  • Drug: Pomalidomide
    Participants will receive pomalidomide.
  • Drug: Lenalidomide
    Participants will receive lenalidomide.
  • Drug: Bortezomib
    Participants will receive bortezomib.
  • Drug: Nirogacestat
    Participants will receive nirogacestat.
Study Arms  ICMJE
  • Experimental: Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
    Participants will receive teclistamab plus daratumumab plus pomalidomide.
    Interventions:
    • Drug: Teclistamab
    • Drug: Daratumumab
    • Drug: Pomalidomide
  • Experimental: Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)
    Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
    Interventions:
    • Drug: Teclistamab
    • Drug: Daratumumab
    • Drug: Lenalidomide
    • Drug: Bortezomib
  • Experimental: Treatment Regimen C: Teclistamab + Nirogacestat
    Participants will receive teclistamab plus nirogacestat.
    Interventions:
    • Drug: Teclistamab
    • Drug: Nirogacestat
  • Experimental: Treatment Regimen D: Teclistamab + Lenalidomide
    Participants will receive teclistamab plus lenalidomide.
    Interventions:
    • Drug: Teclistamab
    • Drug: Lenalidomide
  • Experimental: Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide
    Participants will receive teclistamab plus daratumumab plus lenalidomide.
    Interventions:
    • Drug: Teclistamab
    • Drug: Daratumumab
    • Drug: Lenalidomide
  • Experimental: Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)
    Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
    Interventions:
    • Drug: Teclistamab
    • Drug: Daratumumab
    • Drug: Lenalidomide
    • Drug: Bortezomib
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: March 24, 2022)
146
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2021)
60
Estimated Study Completion Date  ICMJE September 6, 2024
Estimated Primary Completion Date May 19, 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
  • Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
  • Have measurable disease at screening as defined by at least one of the following: serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
  • A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study treatment

Exclusion Criteria:

  • Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C
  • Live, attenuated vaccine within 30 days 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
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,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04722146
Other Study ID Numbers  ICMJE CR108927
2020-004404-33 ( EudraCT Number )
64007957MMY1004 ( Other Identifier: Janssen Research & Development, LLC )
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 September 2022

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