Teclistamab for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Multiple MyelomaTeclistamab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety and tolerability of teclistamab when combined with other drugs. The goal is to find the best dose of the combination.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Study Objectives

4 Primary · 12 Secondary · Reporting Duration: Up to 2 year and 5 months

Year 2
Complete Response (CR) or Better Response Rate
Duration of Response
Number of Participants with AEs by Severity
Number of Participants with Abnormalities in Laboratory Values
Number of Participants with Incidence of Adverse Events (AEs)
Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab
Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab
Overall Response Rate (ORR)
Serum Concentrations of Daratumumab
Serum Concentrations of Nirogacestat
Serum Concentrations of Teclistamab
Stringent Complete Response (sCR) Rate
Time to Response
Very Good Partial Response (VGPR) or Better Response Rate
Day 28
Number of Participants with Dose-Limiting Toxicity (DLT)

Trial Safety

Trial Design

7 Treatment Groups

Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib
1 of 7
Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
1 of 7
Treatment Regimen D: Teclistamab + Lenalidomide
1 of 7
Treatment Regimen C: Teclistamab + Nirogacestat
1 of 7
Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-d...
1 of 7
Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide
1 of 7
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-d...
1 of 7

Experimental Treatment

140 Total Participants · 7 Treatment Groups

Primary Treatment: Teclistamab · No Placebo Group · Phase 1

Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + BortezomibExperimental Group · 4 Interventions: Daratumumab, Teclistamab, Lenalidomide, Bortezomib · Intervention Types: Drug, Drug, Drug, Drug
Treatment Regimen A: Teclistamab + Daratumumab + PomalidomideExperimental Group · 3 Interventions: Daratumumab, Teclistamab, Pomalidomide · Intervention Types: Drug, Drug, Drug
Treatment Regimen D: Teclistamab + LenalidomideExperimental Group · 2 Interventions: Teclistamab, Lenalidomide · Intervention Types: Drug, Drug
Treatment Regimen C: Teclistamab + NirogacestatExperimental Group · 2 Interventions: Teclistamab, Nirogacestat · Intervention Types: Drug, Drug
Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)Experimental Group · 4 Interventions: Daratumumab, Teclistamab, Lenalidomide, Bortezomib · Intervention Types: Drug, Drug, Drug, Drug
Treatment Regimen E: Teclistamab + Daratumumab + LenalidomideExperimental Group · 3 Interventions: Daratumumab, Teclistamab, Lenalidomide · Intervention Types: Drug, Drug, Drug
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)Experimental Group · 4 Interventions: Daratumumab, Teclistamab, Lenalidomide, Bortezomib · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Lenalidomide
FDA approved
Pomalidomide
FDA approved
Bortezomib
FDA approved
Nirogacestat
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 year and 5 months

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
926 Previous Clinical Trials
6,346,019 Total Patients Enrolled
65 Trials studying Multiple Myeloma
17,460 Patients Enrolled for Multiple Myeloma
Janssen Research and Development, LLC Clinical TrialStudy DirectorJanssen Research and Development LLC
9 Previous Clinical Trials
448,119 Total Patients Enrolled
1 Trials studying Multiple Myeloma
152 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a documented initial diagnosis of multiple myeloma according to the IMWG diagnostic criteria.
You 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.