Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) 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 patients with multiple myeloma who have received at least one prior therapy.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: Up to 9 years

Year 9
Change from Baseline in Symptoms, Functioning, and 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)
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Day 15
Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Year 7
Progression Free Survival (PFS)
Up to 7 years
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)
Up to 9 years
Complete Response (CR) or Better
Chromium
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of Participants with Abnormalities in Laboratory Parameters
Number of Participants with Abnormalities in Physical Examination
Number of Participants with Abnormalities in Vital Signs
Number of Participants with Adverse Events (AEs) by Severity
Antibodies
Overall Survival (OS)
Progression Free Survival on Next-line Therapy (PFS2)
Serum Concentrations of Teclistamab
Time to Sustained Worsening in Symptoms, Functioning, and HRQoL
Very Good Partial Response (VGPR) or Better

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
1 of 2
Teclistamab, Daratumumab SC, Lenalidomide (Tec-DR)
1 of 2

Experimental Treatment

1030 Total Participants · 2 Treatment Groups

Primary Treatment: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) · No Placebo Group · Phase 3

Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)Experimental Group · 3 Interventions: Lenalidomide, Daratumumab, Dexamethasone · Intervention Types: Drug, Drug, Drug
Teclistamab, Daratumumab SC, Lenalidomide (Tec-DR)Experimental Group · 3 Interventions: Teclistamab, Lenalidomide, Daratumumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1590
Daratumumab
2016
Completed Phase 4
~1340
Dexamethasone
2007
Completed Phase 4
~2420

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 9 years

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,325,855 Total Patients Enrolled
63 Trials studying Multiple Myeloma
16,794 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
707 Previous Clinical Trials
3,898,833 Total Patients Enrolled
46 Trials studying Multiple Myeloma
11,932 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 are a male and you agree not to plan to father a child while enrolled in this study or within 3 months after the last dose of study treatment.
You have an ECOG performance status score of 0 to 2.
You are female and not pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: November 15th, 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.