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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05050097
Collaborator
(none)
176
Enrollment
34
Locations
5
Arms
25.3
Anticipated Duration (Months)
5.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
176 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Actual Study Start Date :
Sep 22, 2021
Anticipated Primary Completion Date :
Aug 15, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

ArmIntervention/Treatment
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.

Drug: Talquetamab
Talquetamab will be administered subcutaneously.
Other Names:
  • JNJ-64407564
  • Drug: Carfilzomib
    Carfilzomib will be administered as an IV infusion.

    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.

    Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other Names:
  • JNJ-64407564
  • Drug: Carfilzomib
    Carfilzomib will be administered as an IV infusion.

    Drug: Daratumumab SC
    Daratumumab will be administered subcutaneously.

    Experimental: Treatment Regimen C: Talquetamab + Lenalidomide

    Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.

    Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other Names:
  • JNJ-64407564
  • Drug: Lenalidomide
    Lenalidomide will be self-administered orally.

    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.

    Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other Names:
  • JNJ-64407564
  • Drug: Daratumumab SC
    Daratumumab will be administered subcutaneously.

    Drug: Lenalidomide
    Lenalidomide will be self-administered orally.

    Experimental: Treatment Regimen E: Talquetamab + Pomalidomide

    Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.

    Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other Names:
  • JNJ-64407564
  • Drug: Pomalidomide
    Pomalidomide will be self-administered orally.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [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.

    2. Number of Participants with AEs by Severity [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.

    3. Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters [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.

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

    Secondary Outcome Measures

    1. Overall Response Rate (ORR) [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.

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

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

    4. Stringent Complete Response (sCR) [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.

    5. Duration of Response [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.

    6. Time to Response [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.

    7. Serum Concentration of Talquetamab [Up to 1 year and 10 months]

      Serum samples will be analyzed to determine concentrations of talquetamab.

    8. Serum Concentration of Daratumumab [Up to 1 year and 10 months]

      Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D.

    9. Number of Participants with Anti-Drug Antibodies to Talquetamab [Up to 1 year and 10 months]

      Number of participants with anti-drug antibodies to talquetamab will be reported.

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

    11. Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) [Up to 1 year and 10 months]

      Number of participants with anti-drug antibodies to rHuPH20 will be reported.

    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

    • 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Alabama BirminghamBirminghamAlabamaUnited States35294
    2University of California, San FranciscoSan FranciscoCaliforniaUnited States94143
    3Colorado Blood Cancer InstituteDenverColoradoUnited States80218
    4Emory UniversityAtlantaGeorgiaUnited States30322
    5Indiana UniversityIndianapolisIndianaUnited States46202
    6University of Kansas Cancer CenterWestwoodKansasUnited States66160
    7Washington University School of MedicineSaint LouisMissouriUnited States63110-1032
    8Hackensack University Medical CenterHackensackNew JerseyUnited States07601
    9Mt. Sinai School of MedicineNew YorkNew YorkUnited States10029
    10Weill Cornell Medical CollegeNew YorkNew YorkUnited States10065
    11Levine Cancer InstituteCharlotteNorth CarolinaUnited States28204
    12University of Pittsburgh Medical CenterPittsburghPennsylvaniaUnited States15232
    13Sarah Cannon Research InstituteNashvilleTennesseeUnited States37203
    14Seattle Cancer Care AllianceSeattleWashingtonUnited States98109
    15Medical College Of WisconsinMilwaukeeWisconsinUnited States53226
    16St. Vincent's Hospital MelbourneFitzroyAustralia3065
    17Alfred HealthMelbourneAustralia3004
    18Gold Coast University HospitalSouthportAustralia4215
    19Wollongong HospitalWollongongAustralia2500
    20Cliniques Universitaires St-LucBrusselBelgium1200
    21UZAEdegemBelgium2650
    22UZ GentGentBelgium9000
    23UZ LeuvenLeuvenBelgium3000
    24Centre Leon BérardLyon Cedex 8France69373
    25CHU NantesNantes Cedex 1France44093
    26CHU de Bordeaux - Hôpital Haut-LévêquePessac cedexFrance33604
    27Chu Rennes - Hopital PontchaillouRennesFrance35000
    28Institut Universitaire du cancer de Toulouse-OncopoleTOULOUSE Cedex 9France31059
    29UMCGGroningenNetherlands9713 GZ
    30Maastricht University Medical CentreMaastrichtNetherlands6229 HX
    31UMCUUtrechtNetherlands3584 CX
    32University College Hospital LondonLondonUnited KingdomW1T 7HA
    33The Christie Nhs Foundation TrustManchesterUnited KingdomM20 4BX
    34The Royal Marsden NHS Trust SuttonSurreyUnited KingdomSM2 5PT

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05050097
    Other Study ID Numbers:
    • CR108946
    • 2020-004502-55
    • 64407564MMY1004
    First Posted:
    Sep 20, 2021
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Dec 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 Dec 3, 2021