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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT06151717

Collaborator

(none)

2,370

Enrollment

Locations

26.7

Anticipated Duration (Months)

592.5

Patients Per Site

22.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVE:

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 Design

Study Type:

Observational

Anticipated Enrollment :

2370 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 21, 2023

Anticipated Primary Completion Date :

Dec 12, 2025

Anticipated Study Completion Date :

Dec 12, 2025

Arms and Interventions

Arm	Intervention/Treatment
Observational Patients have their medical records reviewed on study.	Other: Non-Interventional Study Non-interventional study

Arm

Intervention/Treatment

Observational

Patients have their medical records reviewed on study.

Other: Non-Interventional Study

Non-interventional study

Outcome Measures

Primary Outcome Measures

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 participants starts the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
4	Mayo Clinic Health System-Franciscan Healthcare	La Crosse	Wisconsin	United States	54601

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Shaji K. Kumar, M.D., Mayo Clinic in Rochester

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT06151717

Other Study ID Numbers:

23-006335
NCI-2023-09520
MC230811
PRAGMMATIC
23-006335

First Posted:

Nov 30, 2023

Last Update Posted:

Nov 30, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Nov 30, 2023