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

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

Completed

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

Overall survival

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Nov 30, 2023
Registry last updated: Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed