Daratumumab for Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
The First Bethune Hospital of Jilin University, Changchun, China
Multiple Myeloma
Daratumumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma who are actively receiving daratumumab in a Janssen Research and Development (R&D)-sponsored daratumumab study which has reached clinical cutoff for final analysis and who continue to benefit from study treatment. Certain long-term safety data will continue to be collected from study participants.

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Multiple Myeloma

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 3 years 7 months

3 years 7 months
Number of Participants with AEs of Special Interest (AESI)
Number of Participants with Abnormal Pregnancies as SAE
Number of Participants with Pregnancies or Partner Pregnancies
Number of Participants with Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

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

Other trials for Multiple Myeloma

Trial Design

1 Treatment Group

Daratumumab
1 of 1
Experimental Treatment

400 Total Participants · 1 Treatment Group

Primary Treatment: Daratumumab · No Placebo Group · Phase 3

DaratumumabExperimental Group · 5 Interventions: Daratumumab, Pomalidomide, Dexamethasone, Carfilzomib, Lenalidomide · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2016
Completed Phase 4
~1400
Pomalidomide
2011
Completed Phase 2
~1330
Dexamethasone
2007
Completed Phase 4
~2420
Carfilzomib
2014
Completed Phase 3
~1400
Lenalidomide
2005
Completed Phase 3
~1590

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years 7 months
Closest Location: Baylor University Medical Center · Dallas, TX
Photo of Dallas 1Photo of Dallas 2Photo of Dallas 3
2002First Recorded Clinical Trial
12 TrialsResearching Multiple Myeloma
217 CompletedClinical Trials

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
916 Previous Clinical Trials
6,326,468 Total Patients Enrolled
62 Trials studying Multiple Myeloma
16,803 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
705 Previous Clinical Trials
3,899,763 Total Patients Enrolled
45 Trials studying Multiple Myeloma
11,941 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
You are willing and able to comply with the lifestyle restrictions specified in this protocol.

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.