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NCT Number: NCT04722146

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

The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

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
  • Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
  • Have measurable disease at screening as defined by at least one of the following: serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
  • A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study treatment

Exclusion criteria

  • Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C
  • Live, attenuated vaccine within 30 days 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

Treatment and study plan

Teclistamab

Drug

Participants will receive teclistamab.

Other names: JNJ-64007957

Daratumumab

Drug

Participants will receive daratumumab.

Pomalidomide

Drug

Participants will receive pomalidomide.

Lenalidomide

Drug

Participants will receive lenalidomide.

bortezomib

Drug

Participants will receive bortezomib.

Nirogacestat

Drug

Participants will receive nirogacestat.

Primary outcomes

  1. Number of Participants with Incidence of Adverse Events (AEs)

    Time frame: Up to 2 year and 5 months

    An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.

  2. Number of Participants with AEs by Severity

    Time frame: Up to 2 year and 5 months

    Number of participants with AEs by severity will be reported.

  3. Number of Participants with Abnormalities in Laboratory Values

    Time frame: Up to 2 year and 5 months

    Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.

  4. Number of Participants with Dose-Limiting Toxicity (DLT)

    Time frame: Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)

    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.

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 2 year and 5 months

    ORR is defined as the proportion of participants who achieve partial response (PR) or better according to the international myeloma working group (IMWG) 2016 criteria.

  2. Very Good Partial Response (VGPR) or Better Response Rate

    Time frame: Up to 2 year and 5 months

    VGPR or better response rate is defined as the proportion 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 2 year and 5 months

    CR or better response rate is defined as the proportion of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.

  4. Stringent Complete Response (sCR) Rate

    Time frame: Up to 2 year and 5 months

    sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.

  5. Duration of Response

    Time frame: Up to 2 year and 5 months

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

  6. Time to Response

    Time frame: Up to 2 year and 5 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 Concentrations of Teclistamab

    Time frame: Up to 2 year and 5 months

    Serum concentrations of teclistamab will be reported.

  8. Serum Concentrations of Daratumumab

    Time frame: Up to 2 year and 5 months

    Serum concentrations of daratumumab will be reported.

  9. Serum Concentrations of Nirogacestat

    Time frame: Up to 2 year and 5 months

    Serum concentration of nirogacestat will be reported.

  10. Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab

    Time frame: Up to 2 year and 5 months

    Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.

  11. Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab

    Time frame: Up to 2 year and 5 months

    Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F.

  12. Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)

    Time frame: Up to 2 year and 5 months

    Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: MajesTEC-2

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Jan 25, 2021
Registry last updated
Jul 31, 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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