A Comparative Clinical Study to Determine the Optimal Initial Therapy for Multiple Myeloma
PRAGMMATIC: A Comparative Clinical Trial to Determine the BEST Initial Therapy for Multiple Myeloma
4 other identifiers
observational
50
1 country
4
Brief Summary
This study evaluates the outcomes of patients undergoing initial therapy for multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2023
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2023
CompletedFirst Submitted
Initial submission to the registry
November 22, 2023
CompletedFirst Posted
Study publicly available on registry
November 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2025
CompletedJune 17, 2025
June 1, 2025
1.7 years
November 22, 2023
June 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival, defined as the time from initiation of therapy to the time of death due to any cause, will be assessed by review of medical record, contacting the participant, or contacting the participant's local physician every 3 months for up to 10 years after participant starts the study.
Every 3 months, up to 10 years
Study Arms (1)
Observational
Patients have their medical records reviewed on study.
Interventions
Eligibility Criteria
Patients with previously untreated multiple myeloma
You may qualify if:
- Previously untreated active multiple myeloma starting a new treatment for the disease with one of the three established treatment regimens: VRd (bortezomib, lenalidomide, dexamethasone), DRd (daratumumab lenalidomide dexamethasone), or DVRd (daratumumab, bortezomib, lenalidomide, and dexamethasone)
- No prior treatment for myeloma
- Not receiving concurrent treatment for another active malignancy
- No more than 3 months from start of treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (4)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaji K. Kumar, MD
Mayo Clinic in Rochester
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2023
First Posted
November 30, 2023
Study Start
September 21, 2023
Primary Completion
June 5, 2025
Study Completion
June 5, 2025
Last Updated
June 17, 2025
Record last verified: 2025-06