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)
100
Enrollment
28
Locations
5
Arms
28
Anticipated Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

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 :
100 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 :
Oct 11, 2022
Anticipated Study Completion Date :
Jul 13, 2023

Arms and Interventions

ArmIntervention/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

    Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib.

    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.

    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, and E.

    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, and E.

    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 multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD

    • 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

    SiteCityStateCountryPostal Code
    1University of Alabama at BirminghamBirminghamAlabamaUnited States35294
    2University of California, San FranciscoSan FranciscoCaliforniaUnited States94143
    3Colorado Blood Cancer InstituteDenverColoradoUnited States80218
    4Emory UniversityAtlantaGeorgiaUnited States30322
    5Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndianaUnited States46202
    6University of KansasWestwoodKansasUnited States66205
    7Washington University School of MedicineSaint LouisMissouriUnited States63110-1032
    8Hackensack University Medical CenterHackensackNew JerseyUnited States07601
    9Memorial Sloan-Kettering Cancer CenterNew YorkNew YorkUnited States10021
    10Mount Sinai Medical CenterNew YorkNew YorkUnited States10029
    11Weill Cornell Medical CollegeNew YorkNew YorkUnited States10065
    12Levine Cancer InstituteCharlotteNorth CarolinaUnited States28204
    13University of Pittsburgh Medical CenterPittsburghPennsylvaniaUnited States15232
    14Sarah Cannon Research InstituteNashvilleTennesseeUnited States37203
    15Seattle Cancer Care AllianceSeattleWashingtonUnited States98109
    16Medical College Of WisconsinMilwaukeeWisconsinUnited States53226
    17St. Vincent's Hospital MelbourneFitzroyAustralia3065
    18Alfred HealthMelbourneAustralia3004
    19Calvary Mater Newcastle HospitalWaratahAustralia2298
    20UZAEdegemBelgium2650
    21UZ GentGentBelgium9000
    22CHU NantesNantes Cedex 1France44093
    23CHU de Bordeaux - Hôpital Haut-LévêquePessac cedexFrance33604
    24Chu Rennes - Hopital PontchaillouRennesFrance35000
    25Institut Universitaire du cancer de Toulouse-OncopoleTOULOUSE Cedex 9France31059
    26University College HospitalLondonUnited KingdomNW1 2BU
    27The Christie Nhs Foundation TrustManchesterUnited KingdomM20 4BX
    28The Royal Marsden NHS Trust SuttonSurreyUnited KingdomSM2 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

    Additional 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:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    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 Oct 8, 2021