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NCT Number: NCT05050097

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Vincents Hospital Melbourne, Fitzroy, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Talquetamab

Drug

Talquetamab will be administered subcutaneously.

Other names: JNJ-64407564

Carfilzomib

Drug

Carfilzomib will be administered as an IV infusion.

Daratumumab SC

Drug

Daratumumab will be administered subcutaneously.

Lenalidomide

Drug

Lenalidomide will be self-administered orally.

Pomalidomide

Drug

Pomalidomide will be self-administered orally.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Acronym: MonumenTAL-2

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Sep 20, 2021
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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