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A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MonumenTAL-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: NCT05050097
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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
Multiple Myeloma Drug: Talquetamab Drug: Carfilzomib Drug: Daratumumab SC Drug: Lenalidomide Drug: Pomalidomide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 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 : September 22, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : August 5, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: JNJ-64407564

Drug: Pomalidomide
Pomalidomide will be self-administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 1 year and 10 months ]
    Serum samples will be analyzed to determine concentrations of talquetamab.

  8. Serum Concentration of Daratumumab [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to 1 year and 10 months ]
    Number of participants with anti-drug antibodies to rHuPH20 will be reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050097


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05050097    
Other Study ID Numbers: CR108946
2020-004502-55 ( EudraCT Number )
64407564MMY1004 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
 Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Pomalidomide
Daratumumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents