Clinical Trials /

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

NCT04722146

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
  • Official Title: A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: CR108927
  • SECONDARY ID: 2020-004404-33
  • SECONDARY ID: 64007957MMY1004
  • NCT ID: NCT04722146

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
TeclistamabJNJ-64007957Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
DaratumumabTreatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
PomalidomideTreatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
LenalidomideTreatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib
BortezomibTreatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib
NirogacestatTreatment Regimen C: Teclistamab + Nirogacestat

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Treatment Regimen A: Teclistamab + Daratumumab + PomalidomideExperimentalParticipants will receive teclistamab plus daratumumab plus pomalidomide.
  • Teclistamab
  • Daratumumab
  • Pomalidomide
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + BortezomibExperimentalParticipants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib.
  • Teclistamab
  • Daratumumab
  • Lenalidomide
  • Bortezomib
Treatment Regimen C: Teclistamab + NirogacestatExperimentalParticipants will receive teclistamab plus nirogacestat.
  • Teclistamab
  • Nirogacestat

Eligibility Criteria

        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 at least 1 prior line 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)

          -  Have measurable disease at screening as defined by at least one of the following:
             serum M-protein level greater than or equal to (>=) 1.0 gram/deciliter (g/dL); or
             urine M-protein level >= 200 milligram (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

          -  A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during the study and for at least 100 days after the last dose of study
             treatment

        Exclusion Criteria:

          -  Prior treatment with any therapy that targets B-cell maturation antigen (BCMA)

          -  Live, attenuated vaccine within 4 weeks before the first dose of study treatment,
             unless approved by sponsor

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Incidence of Adverse Events (AEs)
Time Frame:Up to 53 weeks
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to 53 weeks
Safety Issue:
Description: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.
Measure:Very Good Partial Response (VGPR) or Better Response Rate
Time Frame:Up to 53 weeks
Safety Issue:
Description: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.
Measure:Complete Response (CR) or Better Response Rate
Time Frame:Up to 53 weeks
Safety Issue:
Description: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.
Measure:Stringent Complete Response (sCR) Rate
Time Frame:Up to 53 weeks
Safety Issue:
Description:sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.
Measure:Duration of Response
Time Frame:Up to 53 weeks
Safety Issue:
Description: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.
Measure:Time to Response
Time Frame:Up to 53 weeks
Safety Issue:
Description: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.
Measure:Serum Concentrations of Teclistamab
Time Frame:Up to 53 weeks
Safety Issue:
Description:Serum concentrations of teclistamab will be reported.
Measure:Serum Concentrations of Daratumumab
Time Frame:Up to 53 weeks
Safety Issue:
Description:Serum concentrations of daratumumab will be reported.
Measure:Serum Concentrations of Nirogacestat
Time Frame:Up to 53 weeks
Safety Issue:
Description:Serum concentration of nirogacestat will be reported.
Measure:Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab
Time Frame:Up to 53 weeks
Safety Issue:
Description:Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.
Measure:Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab
Time Frame:Up to 53 weeks
Safety Issue:
Description:Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A and Treatment Regimen B.
Measure:Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Time Frame:Up to 53 weeks
Safety Issue:
Description:Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A and Treatment Regimen B.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

February 1, 2021