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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06151717
Enrollment
50
Registered
2023-11-30
Start date
2023-09-21
Completion date
2025-06-05
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

This study evaluates the outcomes of patients undergoing initial therapy for multiple myeloma.

Detailed description

PRIMARY OBJECTIVE: I. Compare the overall survival between bortezomib, lenalidomide and dexamethasone (VRd), daratumumab, lenalidomide and dexamethasone (DRd) and daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) used as initial therapy for patients with newly diagnosed MM. OUTLINE: This is an observational study. Patients have their medical records reviewed on study.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Does not meet all inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Overall survivalEvery 3 months, up to 10 yearsOverall 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026