Teclistamab for Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Multiple Myeloma+1 More
Teclistamab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of two different combinations of drugs for treating myeloma.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Multiple Myeloma

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: Up to 5 years

Year 5
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF 8c)
Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Month 6
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE )
Up to 5 years
Complete Response (CR) or Better
Depth of Response in Participants in High-risk Molecular Features
Duration of Response
Minimal Residual Disease (MRD)-negativity
Number of Participants with Adverse Events (AEs) by Severity
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Daratumumab
Overall Response (Partial Response [PR] or Better)
Overall Survival (OS)
PFS in Participants with High-risk Molecular Features
Progression Free Survival (PFS)
Progression Free Survival on Next-line Therapy (PFS2)
Serum Concentration of Teclistamab
Time to Next Treatment (TTNT)
Time to Worsening of Symptoms
Very Good Partial Response (VGPR) or Better

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Multiple Myeloma

Trial Design

5 Treatment Groups

Part 1: Arm A: Teclistamab-daratumumab (Tec-Dara)
1 of 5
Part 2: Tec-Dara
1 of 5
Part 1: Arm B: DPd or DVd
1 of 5
Arm A: Teclistamab-daratumumab (Tec-Dara)
1 of 5
Arm B:Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Bortezomib,...
1 of 5
Experimental Treatment

630 Total Participants · 5 Treatment Groups

Primary Treatment: Teclistamab · No Placebo Group · Phase 3

Part 1: Arm A: Teclistamab-daratumumab (Tec-Dara)Experimental Group · 2 Interventions: Daratumumab, Teclistamab · Intervention Types: Drug, Drug
Part 2: Tec-DaraExperimental Group · 2 Interventions: Daratumumab, Teclistamab · Intervention Types: Drug, Drug
Part 1: Arm B: DPd or DVdExperimental Group · 4 Interventions: Dexamethasone, Bortezomib, Daratumumab, Pomalidomide · Intervention Types: Drug, Drug, Drug, Drug
Arm A: Teclistamab-daratumumab (Tec-Dara)Experimental Group · 2 Interventions: Daratumumab, Teclistamab · Intervention Types: Drug, Drug
Arm B:Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Bortezomib, Dexamethasone (DVd)Experimental Group · 4 Interventions: Dexamethasone, Bortezomib, Daratumumab, Pomalidomide · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Bortezomib
FDA approved
Daratumumab
FDA approved
Pomalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,326,536 Total Patients Enrolled
63 Trials studying Multiple Myeloma
17,136 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
707 Previous Clinical Trials
3,899,514 Total Patients Enrolled
46 Trials studying Multiple Myeloma
12,274 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 received 1 to 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a.
You have an ECOG performance status score of 0, 1, or 2 at screening and prior to the start of study treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Illinois100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Medical College Of Wisconsin100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%