Daratumumab for Multiple Myeloma

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

Study Summary

This trial is testing a new combination of drugs to treat multiple myeloma that has come back or is not responding to treatment.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Up to approximately 5 years

Less than 1 year
European Quality of Life 5-Dimension 5-Level (EQ-5D-5L)
Year 1
Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))
Maximum plasma concentration (Cmax)
Recommended iberdomide dose for Stage 2
Time to maximum plasma concentration (Tmax)
Year 5
Duration of Response (DoR)
European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
Minimal Residual Disease (MRD) negativity rate
Overall Response Rate (ORR)
Overall Survival (OS)
Progression-free Survival (PFS)
Progression-free Survival 2 (PFS2)
Safety
Time to Next Treatment (TTNT)
Time to Progression (TTP)
Time to response (TTR)

Trial Safety

Safety Progress

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

Trial Design

9 Treatment Groups

Daratumumab in combination with dexamethasone and bortezomib
1 of 9
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
1 of 9
Daratumumab in combination with CC-220 and dexamethasone - Dose 2
1 of 9
Daratumumab in combination with CC-220 and dexamethasone - Dose 1
1 of 9
CC-220 in combination with dexamethasone and daratumumab
1 of 9
Daratumumab in combination with bortezomib and dexamethasone
1 of 9
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
1 of 9
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
1 of 9
Daratumumab in combination with CC-220 and dexamethasone - Dose 3
1 of 9
Active Control
Experimental Treatment

864 Total Participants · 9 Treatment Groups

Primary Treatment: Daratumumab · No Placebo Group · Phase 3

Daratumumab in combination with Iberdomide and dexamethasone - Dose 3Experimental Group · 3 Interventions: Daratumumab, Dexamethasone, Iberdomide · Intervention Types: Drug, Drug, Drug
Daratumumab in combination with CC-220 and dexamethasone - Dose 2Experimental Group · 3 Interventions: Daratumumab, Dexamethasone, CC-220 · Intervention Types: Drug, Drug, Drug
Daratumumab in combination with CC-220 and dexamethasone - Dose 1Experimental Group · 3 Interventions: Daratumumab, Dexamethasone, CC-220 · Intervention Types: Drug, Drug, Drug
CC-220 in combination with dexamethasone and daratumumabExperimental Group · 3 Interventions: Daratumumab, Dexamethasone, CC-220 · Intervention Types: Drug, Drug, Drug
Daratumumab in combination with bortezomib and dexamethasoneExperimental Group · 3 Interventions: Daratumumab, Dexamethasone, Bortezomib · Intervention Types: Drug, Drug, Drug
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2Experimental Group · 3 Interventions: Daratumumab, Dexamethasone, Iberdomide · Intervention Types: Drug, Drug, Drug
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1Experimental Group · 3 Interventions: Daratumumab, Dexamethasone, Iberdomide · Intervention Types: Drug, Drug, Drug
Daratumumab in combination with CC-220 and dexamethasone - Dose 3Experimental Group · 3 Interventions: Daratumumab, Dexamethasone, CC-220 · Intervention Types: Drug, Drug, Drug
Daratumumab in combination with dexamethasone and bortezomibActiveComparator Group · 3 Interventions: Daratumumab, Dexamethasone, Bortezomib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Dexamethasone
FDA approved
Bortezomib
FDA approved
CC-220
Not yet FDA approved

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

CelgeneLead Sponsor
625 Previous Clinical Trials
172,262 Total Patients Enrolled
139 Trials studying Multiple Myeloma
38,598 Patients Enrolled for Multiple Myeloma
April Sorrell, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,394 Previous Clinical Trials
3,306,810 Total Patients Enrolled
62 Trials studying Multiple Myeloma
20,932 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have received 1 to 2 prior lines of anti-myeloma therapy.
You have documented a diagnosis of MM and measurable disease.
You have a performance status score of 0, 1 or 2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 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.