A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04722146
Collaborator
(none)
146
29
6
41.9
5
0.1

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Actual Study Start Date :
Mar 12, 2021
Anticipated Primary Completion Date :
May 19, 2023
Anticipated Study Completion Date :
Sep 6, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide

Participants will receive teclistamab plus daratumumab plus pomalidomide.

Drug: Teclistamab
Participants will receive teclistamab.
Other Names:
  • JNJ-64007957
  • Drug: Daratumumab
    Participants will receive daratumumab.

    Drug: Pomalidomide
    Participants will receive 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.

    Drug: Teclistamab
    Participants will receive teclistamab.
    Other Names:
  • JNJ-64007957
  • Drug: Daratumumab
    Participants will receive daratumumab.

    Drug: Lenalidomide
    Participants will receive lenalidomide.

    Drug: Bortezomib
    Participants will receive bortezomib.

    Experimental: Treatment Regimen C: Teclistamab + Nirogacestat

    Participants will receive teclistamab plus nirogacestat.

    Drug: Teclistamab
    Participants will receive teclistamab.
    Other Names:
  • JNJ-64007957
  • Drug: Nirogacestat
    Participants will receive nirogacestat.

    Experimental: Treatment Regimen D: Teclistamab + Lenalidomide

    Participants will receive teclistamab plus lenalidomide.

    Drug: Teclistamab
    Participants will receive teclistamab.
    Other Names:
  • JNJ-64007957
  • Drug: Lenalidomide
    Participants will receive lenalidomide.

    Experimental: Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide

    Participants will receive teclistamab plus daratumumab plus lenalidomide.

    Drug: Teclistamab
    Participants will receive teclistamab.
    Other Names:
  • JNJ-64007957
  • Drug: Daratumumab
    Participants will receive daratumumab.

    Drug: Lenalidomide
    Participants will receive 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.

    Drug: Teclistamab
    Participants will receive teclistamab.
    Other Names:
  • JNJ-64007957
  • Drug: Daratumumab
    Participants will receive daratumumab.

    Drug: Lenalidomide
    Participants will receive lenalidomide.

    Drug: Bortezomib
    Participants will receive bortezomib.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Incidence of Adverse Events (AEs) [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.

    2. Number of Participants with AEs by Severity [Up to 2 year and 5 months]

      Number of participants with AEs by severity will be reported.

    3. Number of Participants with Abnormalities in Laboratory Values [Up to 2 year and 5 months]

      Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.

    4. Number of Participants with Dose-Limiting Toxicity (DLT) [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.

    Secondary Outcome Measures

    1. Overall Response Rate (ORR) [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.

    2. Very Good Partial Response (VGPR) or Better Response Rate [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.

    3. Complete Response (CR) or Better Response Rate [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.

    4. Stringent Complete Response (sCR) Rate [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.

    5. Duration of Response [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.

    6. Time to Response [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.

    7. Serum Concentrations of Teclistamab [Up to 2 year and 5 months]

      Serum concentrations of teclistamab will be reported.

    8. Serum Concentrations of Daratumumab [Up to 2 year and 5 months]

      Serum concentrations of daratumumab will be reported.

    9. Serum Concentrations of Nirogacestat [Up to 2 year and 5 months]

      Serum concentration of nirogacestat will be reported.

    10. Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab [Up to 2 year and 5 months]

      Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.

    11. Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab [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.

    12. Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 University of California, San Francisco San Francisco California United States 94143
    3 Colorado Blood Cancer Institute Denver Colorado United States 80218
    4 Emory University Atlanta Georgia United States 30322
    5 Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    6 University of Kansas Westwood Kansas United States 66205
    7 Washington University School of Medicine Saint Louis Missouri United States 63110-1032
    8 Hackensack University Medical Center Hackensack New Jersey United States 07601
    9 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    10 Mount Sinai Medical Center New York New York United States 10029
    11 Weill Cornell Medical College New York New York United States 10065
    12 Levine Cancer Institute Charlotte North Carolina United States 28204
    13 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    14 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    15 Seattle Cancer Care Alliance Seattle Washington United States 98109
    16 Medical College Of Wisconsin Milwaukee Wisconsin United States 53226
    17 St. Vincent's Hospital Melbourne Fitzroy Australia 3065
    18 Alfred Health Melbourne Australia 3004
    19 Calvary Mater Newcastle Hospital Waratah Australia 2298
    20 UZA Edegem Belgium 2650
    21 UZ Gent Gent Belgium 9000
    22 Centre Leon Bérard Lyon Cedex 8 France 69373
    23 CHU Nantes Nantes Cedex 1 France 44093
    24 CHU de Bordeaux - Hôpital Haut-Lévêque Pessac cedex France 33604
    25 Chu Rennes - Hopital Pontchaillou Rennes France 35000
    26 Institut Universitaire du cancer de Toulouse-Oncopole TOULOUSE Cedex 9 France 31059
    27 University College Hospital London United Kingdom NW1 2BU
    28 The Christie Nhs Foundation Trust Manchester United Kingdom M20 4BX
    29 The Royal Marsden NHS Trust Sutton Surrey United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research and Development, LLC Clinical Trial, Janssen Research and Development LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04722146
    Other Study ID Numbers:
    • CR108927
    • 2020-004404-33
    • 64007957MMY1004
    First Posted:
    Jan 25, 2021
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 15, 2022