Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd) for Relapsed or Refractory Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Universitaetsklinikum Koeln, Koeln, Germany
Relapsed or Refractory Multiple Myeloma+2 More
Dexamethasone - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab in combination with pomalidomide and dexamethasone (DPd).

Eligible Conditions

  • Relapsed or Refractory Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 24 Secondary · Reporting Duration: Up to 6 years 6 months

Year 6
Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
Year 6
Complete Response (CR) or Better Rate
Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs)
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab
Overall Minimal Residual Disease (MRD) Negative Status
Overall Response (Partial Response [PR] or Better)
Overall Survival (OS)
Progression-Free Survival (PFS)
Progression-free Survival on Next-line Therapy (PFS2)
Serum Concentrations of Talquetamab
Time to Next Therapy (TTNT)
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Very Good Partial Response (VGPR) or Better Rate

Trial Safety

Safety Progress

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

Trial Design

3 Treatment Groups

Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)
1 of 3
Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Poma...
1 of 3
Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)
1 of 3
Experimental Treatment

810 Total Participants · 3 Treatment Groups

Primary Treatment: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd) · No Placebo Group · Phase 3

Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)Experimental Group · 2 Interventions: Dexamethasone, Pomalidomide · Intervention Types: Drug, Drug
Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)Experimental Group · 4 Interventions: Dexamethasone, Daratumumab, Talquetamab, Pomalidomide · Intervention Types: Drug, Drug, Drug, Drug
Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)Experimental Group · 3 Interventions: Dexamethasone, Daratumumab, Talquetamab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2420
Daratumumab
2016
Completed Phase 4
~1400
Pomalidomide
2011
Completed Phase 2
~1330

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 years 6 months
Closest Location: Seattle Cancer Care Alliance · Seattle, WA
Photo of seattle cancer care alliance  1Photo of seattle cancer care alliance  2Photo of seattle cancer care alliance  3
2012First Recorded Clinical Trial
1 TrialsResearching Relapsed or Refractory Multiple Myeloma
240 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide.
You have progressive disease based on the investigator's determination of response by the IMWG criteria on or after their last regimen.
You have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of study treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.