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.
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
Interventions
Drug | Synonyms | Arms |
---|
Teclistamab | JNJ-64007957 | Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide |
Daratumumab | | Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide |
Pomalidomide | | Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide |
Lenalidomide | | Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib |
Bortezomib | | Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib |
Nirogacestat | | Treatment 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
Name | Type | Description | Interventions |
---|
Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide | Experimental | Participants will receive teclistamab plus daratumumab plus pomalidomide. | - Teclistamab
- Daratumumab
- Pomalidomide
|
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib | Experimental | Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib. | - Teclistamab
- Daratumumab
- Lenalidomide
- Bortezomib
|
Treatment Regimen C: Teclistamab + Nirogacestat | Experimental | Participants will receive teclistamab plus nirogacestat. | |
Treatment Regimen D: Teclistamab + Lenalidomide | Experimental | Participants will receive teclistamab plus lenalidomide. | |
Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide | Experimental | Participants will receive teclistamab plus daratumumab plus lenalidomide. | - Teclistamab
- Daratumumab
- Lenalidomide
|
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 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 multiple myeloma and has received 1 to 3 prior
lines of therapy, including exposure to a PI and an IMiD
- 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 100 days 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
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 2 year and 5 months |
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 2 year and 5 months |
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 2 year and 5 months |
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 2 year and 5 months |
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 2 year and 5 months |
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 2 year and 5 months |
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 2 year and 5 months |
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 2 year and 5 months |
Safety Issue: | |
Description: | Serum concentrations of teclistamab will be reported. |
Measure: | Serum Concentrations of Daratumumab |
Time Frame: | Up to 2 year and 5 months |
Safety Issue: | |
Description: | Serum concentrations of daratumumab will be reported. |
Measure: | Serum Concentrations of Nirogacestat |
Time Frame: | Up to 2 year and 5 months |
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 2 year and 5 months |
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 2 year and 5 months |
Safety Issue: | |
Description: | Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, and E. |
Measure: | 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 |
Safety Issue: | |
Description: | Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, and E. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Janssen Research & Development, LLC |
Last Updated
August 11, 2021