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NCT Number: NCT04586426

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).

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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 / Phase 2

Primary location

St Vincents Hospital Melbourne, Fitzroy, Australia

Loading trial locations.

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 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  • Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration

Exclusion criteria

  • All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy
  • All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment.
  • All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma.
  • All Parts: Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis

Treatment and study plan

Talquetamab

Drug

Talquetamab will be administered by subcutaneous (SC) injection.

Other names: JNJ-64407564

Teclistamab

Drug

Teclistamab will be administered by SC injection.

Other names: JNJ-64007957

Primary outcomes

  1. Part 1: Number of Participants with Dose Limiting Toxicity (DLT)

    Time frame: Approximately 5 years 10 months

    The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.

  2. Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

    Time frame: Approximately 5 years 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 adverse event.

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

    Time frame: Approximately 5 years 10 months

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product, is medically important.

  4. Part 2: Number of Participants with Adverse Events and SAEs by Severity

    Time frame: Approximately 5 years 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 adverse event.

  5. Part 3: Overall Response Rate (ORR)

    Time frame: Approximately 5 years 10 months

    ORR is defined as the percentage of participants who have a partial response (PR) or better according Independent Review Committees (IRC).

Secondary outcomes

  1. Parts 1, 2 and 3: Serum Concentration of Talquetamab

    Time frame: Approximately 5 years 10 months

    Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive immunoassay method.

  2. Parts 1, 2 and 3: Serum Concentration of Teclistamab

    Time frame: Approximately 5 years 10 months

    Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method.

  3. Part 1 and Part 2: Serum Concentration of Daratumumab

    Time frame: Approximately 5 years 10 months

    Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method.

  4. Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Talquetamab

    Time frame: Approximately 5 years 10 months

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

  5. Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Teclistamab

    Time frame: Approximately 5 years 10 months

    Number of participants with anti-drug antibodies to teclistamab will be assessed.

  6. Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab

    Time frame: Approximately 5 years 10 months

    Number of participants with anti-drug antibodies to daratumumab will be assessed.

  7. Part 1 and Part 2: Overall Response Rate (ORR)

    Time frame: Approximately 5 years 10 months

    ORR is defined as the percentage of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.

  8. Parts 1, 2 and 3: Very Good Partial Response (VGPR) or Better Response Rate

    Time frame: Approximately 5 years 10 months

    VGPR or better response rate (sCR+CR+VGPR) is defined as the percentage of participants who achieve a VGPR or better response according to the IMWG criteria.

  9. Parts 1, 2 and 3: Complete Response (CR) or Better Response Rate

    Time frame: Approximately 5 years 10 months

    CR or better response rate (sCR+CR) is defined as the percentage of participants who achieve a CR or better response according to the IMWG criteria.

  10. Part 1, 2 and 3: Stringent Complete Response (sCR) Rate

    Time frame: Approximately 5 years 10 months

    sCR rate is defined as the percentage of participants who achieve a sCR according to the IMWG criteria.

  11. Parts 1, 2 and 3: Duration of Response (DOR)

    Time frame: Approximately 5 years 10 months

    DOR will be calculated among responders (with PR or better) 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 criteria.

  12. Parts 1, 2 and 3: Time to Response

    Time frame: Approximately 5 years 10 months

    Time to response 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.

  13. Part 3: Progression free Survival (PFS)

    Time frame: Approximately 5 years 10 months

    PFS is defined as the time from the date of first dose to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

  14. Part 3: Overall Survival (OS)

    Time frame: Approximately 5 years 10 months

    OS is measured from the date of first dose to the date of the participant's death.

  15. Part 3: Number of Participants with Adverse Events

    Time frame: Approximately 5 years 10 months

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

  16. Part 3: Number of Participants with Adverse Events by Severity

    Time frame: Approximately 5 years 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 adverse event.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Acronym: RedirecTT-1

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Oct 14, 2020
Registry last updated
Jan 16, 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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