Comparing initial therapies for multiple myeloma
PRAGMMATIC: A Comparative Clinical Trial to Determine the BEST Initial Therapy for Multiple Myeloma
This study is testing which of three different treatment combinations helps people with newly diagnosed multiple myeloma live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2370 (estimated) |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | daratumumab |
| Locations | 4 sites (Scottsdale, Arizona and 3 other locations) |
| Trial ID | NCT06151717 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the outcomes of patients with newly diagnosed multiple myeloma who are starting treatment with one of three established regimens: bortezomib, lenalidomide, and dexamethasone (VRd), daratumumab, lenalidomide, and dexamethasone (DRd), or daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd). The primary objective is to compare overall survival rates among these treatment options. Patient medical records will be reviewed to gather data on treatment outcomes and effectiveness.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed active multiple myeloma who have not received any prior treatment.
Not a fit: Patients who have previously received treatment for multiple myeloma or are currently undergoing treatment for another active malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective initial therapy for patients with multiple myeloma, potentially improving survival rates.
How similar studies have performed: Other studies have shown success in comparing treatment regimens for multiple myeloma, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Scottsdale, Arizona and 3 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
- Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Shaji K. Kumar, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.