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NCT Number: NCT03399799

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 [Dose Escalation]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Part 1: Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies. Part 2: Participants with multiple myeloma measurable by central laboratory assessment who have progressed on, or could not tolerate, all available established therapies; Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio; If central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25%
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine
  • Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease

Exclusion criteria

  • Participants who received or plan to receive any live, attenuated vaccine within 4 weeks prior to the first dose, during treatment, or within 4 weeks of the last dose of Talquetamab. Non-live or non-replicating vaccines approved or authorized for emergency use (example, coronavirus disease [COVID]-19) by local health authorities are allowed
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
  • An allogenic stem cell transplant within 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD); and/or an autologous stem cell transplant less than or equal to (<=) 12 weeks before first dose of study drug
  • Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required

Treatment and study plan

Talquetamab

Drug

Participants will receive IV infusion or SC injection of Talquetamab.

Primary outcomes

  1. Part 1: Dose-limiting Toxicity (DLT)

    Time frame: Up to Day 28

    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.

  2. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier [approximately 2.10 years])

    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.

Secondary outcomes

  1. Part 1: Talquetamab Serum Concentrations

    Time frame: Up to 4 weeks

    Serum concentrations will be calculated for Talquetamab.

  2. Part 1 and Part 2: Biomarker Assessment

    Time frame: Up to Cycle 7 Day 1 (each cycle of 21-days)

    Serum cytokine concentrations will be measured pre- and post-infusion of Talquetamab for biomarker assessment.

  3. Part 1: Number of Participants with Talquetamab Antibodies

    Time frame: Up to 4 weeks

    Antibodies to Talquetamab will be assessed to evaluate potential immunogenicity.

  4. Part 2: Overall Response Rate (ORR)

    Time frame: Approximately 2.10 years

    ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.

  5. Part 2: Clinical Benefit Rate (CBR)

    Time frame: Approximately 2.10 years

    CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria.

  6. Part 2: Duration of Response (DOR)

    Time frame: From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (approximately 2.10 years)

    DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.

  7. Part 2: Time to Response (TTR)

    Time frame: From the date of first dose of study drug to the date of initial documentation of a response (approximately 2.10 years)

    TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.

  8. Part 2: Progression-Free Survival (PFS)

    Time frame: Every 16 weeks until end of study, participant dies, withdrawn consent, or lost to follow up (up to 18 months)

    PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

64407564MMY1001: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Acronym: MonumenTAL-1

Important dates

Study start
2017
Primary completion
2022
Study completion
2027
First posted
Jan 16, 2018
Registry last updated
Jul 7, 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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