A Comparative Clinical Study to Determine the Optimal Initial Therapy for Multiple Myeloma

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06151717
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2023-09-21
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-22
• Study First Posted: 2023-11-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2033-12-12
• Study Completion: 2033-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2370

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients have their medical records reviewed on study.

Primary Outcome Measures

Name	Time	Method
Overall survival	Every 3 months, up to 10 years	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.

Trial Locations

Locations (4)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic Health System-Franciscan Healthcare; 🇺🇸 La Crosse, Wisconsin, United States