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Alkylating agents
Lenalidomide for Multiple Myeloma (BuMelMCRN001 Trial)
Phase 2
Waitlist Available
Led By Donna E Reece, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 to 75 years, inclusive.
Study participants must have a diagnosis of symptomatic multiple myeloma requiring systemic therapy and are eligible for the planned ASCT.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization patients will be followed for pfs every 3 months for the first year after asct and then every 6 months until disease progression. after they will be followed every year for o/s until death.
Awards & highlights
BuMelMCRN001 Trial Summary
This study is evaluating whether a novel agent based induction regimen can improve the outcome of autologous stem cell transplantation.
Eligible Conditions
- Multiple Myeloma
BuMelMCRN001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBuMelMCRN001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization patients will be followed for pfs every 3 months for the first year after asct and then every 6 months until disease progression. after they will be followed every year for o/s until death.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization patients will be followed for pfs every 3 months for the first year after asct and then every 6 months until disease progression. after they will be followed every year for o/s until death.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
• Minimal Residual Disease (MRD) negativity at day 100 post ASCT
Secondary outcome measures
• Assessment of using optional cell free DNA (cfDNA) in peripheral blood to monitor and correlate response assessments in multiple myeloma.
• Identification of the type and frequencies of somatic abnormalities (point mutations, indels, and copy number abnormalities) and their evolution overtime.
• To determine the effectiveness of using the HevyLite Chain assay to assess anti-tumour response at day 100 post ASCT and during lenalidomide maintenance
+5 moreBuMelMCRN001 Trial Design
1Treatment groups
Experimental Treatment
Group I: BuMel + lenalidomide MaintenanceExperimental Treatment3 Interventions
I.V. Busulfan + I.V. Melphalan for conditioning prior ASCT, followed by Lenalidomide maintenance at day 100 after ASCT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
FDA approved
Lenalidomide
FDA approved
Busulfan
FDA approved
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,721 Total Patients Enrolled
8 Trials studying Multiple Myeloma
181 Patients Enrolled for Multiple Myeloma
Princess Margaret Hospital, CanadaOTHER
118 Previous Clinical Trials
38,616 Total Patients Enrolled
2 Trials studying Multiple Myeloma
78 Patients Enrolled for Multiple Myeloma
Otsuka Pharmaceutical Development & Commercialization, Inc.Industry Sponsor
245 Previous Clinical Trials
166,857 Total Patients Enrolled
4 Trials studying Multiple Myeloma
270 Patients Enrolled for Multiple Myeloma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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