Questionnaires for Multiple Myeloma

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

Study Summary

This trial will compare the quality of life for patients with newly diagnosed MM who respond well to initial treatment, between those who receive the standard maintenance therapy (lenalidomide) and those who receive daratumumab as maintenance therapy.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 3 years

3 years
Difference in the global health status
difference in overall survival and progression-free survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Daratumumab maintenance
1 of 2
Lenalidomide maintenance
1 of 2

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Questionnaires · No Placebo Group · Phase 2

Daratumumab maintenanceExperimental Group · 2 Interventions: Questionnaires, Daratumumab · Intervention Types: Behavioral, Drug
Lenalidomide maintenanceExperimental Group · 2 Interventions: Questionnaires, Lenalidomide · Intervention Types: Behavioral, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3240
Daratumumab
FDA approved
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,823 Previous Clinical Trials
584,384 Total Patients Enrolled
75 Trials studying Multiple Myeloma
85,677 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
141 Previous Clinical Trials
567,187 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,814 Patients Enrolled for Multiple Myeloma
Urvi Shah, MBBSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Multiple Myeloma
150 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with plasma cell myeloma treated with combination therapy with or without ASCT, who at the time of study enrollment have documented evidence of very good partial response (VGPR) or better according to International Myeloma Workshop Consensus Panel.
You are enrolled within 6 months of completion of initial combination therapy.
Absolute neutrophil count ≥ 1.0K /μL (growth factor support is permissible).
Platelets ≥ 50,000/μL (transfusions are permissible).
Hemoglobin ≥ 8 g/dL (transfusions are permissible).
Creatinine clearance (CrCl) of greater than or equal to 40 mL/min

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 23rd, 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.