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NCT06151717 Clinical Trial

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

Multiple Myeloma Clinical Trial

Official title:
PRAGMMATIC: A Comparative Clinical Trial to Determine the BEST Initial Therapy for Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06151717
Other study ID # 23-006335
Secondary ID NCI-2023-09520MC
Status Recruiting
Phase
First received
Last updated
Start date September 21, 2023
Est. completion date December 12, 2025

Study information
Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2370
Est. completion date December 12, 2025
Est. primary completion date December 12, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
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Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
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