MonumenTAL-2: 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)
234
34
5
34.5
6.9
0.2

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 Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
234 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 :
Aug 7, 2024

Arms and Interventions

Arm Intervention/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

    Site City State Country Postal Code
    1 University of Alabama 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 Indianapolis Indiana United States 46202
    6 University of Kansas Cancer Center Westwood Kansas United States 66160
    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 Mt. Sinai School of Medicine New York New York United States 10029
    10 Weill Cornell Medical College New York New York United States 10065
    11 Levine Cancer Institute Charlotte North Carolina United States 28204
    12 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    13 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    14 Seattle Cancer Care Alliance Seattle Washington United States 98109
    15 Medical College Of Wisconsin Milwaukee Wisconsin United States 53226
    16 St. Vincent's Hospital Melbourne Fitzroy Australia 3065
    17 Alfred Health Melbourne Australia 3004
    18 Gold Coast University Hospital Southport Australia 4215
    19 Wollongong Hospital Wollongong Australia 2500
    20 Cliniques Universitaires St-Luc Brussel Belgium 1200
    21 UZA Edegem Belgium 2650
    22 UZ Gent Gent Belgium 9000
    23 UZ Leuven Leuven Belgium 3000
    24 Centre Leon Bérard Lyon Cedex 8 France 69373
    25 CHU Nantes Nantes Cedex 1 France 44093
    26 CHU de Bordeaux - Hôpital Haut-Lévêque Pessac cedex France 33604
    27 Chu Rennes - Hopital Pontchaillou Rennes France 35000
    28 Institut Universitaire du cancer de Toulouse-Oncopole TOULOUSE Cedex 9 France 31059
    29 UMCG Groningen Netherlands 9713 GZ
    30 Maastricht University Medical Centre Maastricht Netherlands 6229 HX
    31 UMCU Utrecht Netherlands 3584 CX
    32 University College Hospital London London United Kingdom W1T 7HA
    33 The Christie Nhs Foundation Trust Manchester United Kingdom M20 4BX
    34 The Royal Marsden NHS Trust Sutton Surrey United Kingdom SM2 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

    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:
    Aug 12, 2022
    Last Verified:
    Aug 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 Aug 12, 2022