A Comparative Clinical Study to Determine the Optimal Ini... | NCT06151717

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

NCT06151717

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jun 17, 2025Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
NCI-2023-09520	Registry Identifier	CTRP (Clinical Trial Reporting Program)
MC230811	Other Identifier	Mayo Clinic
PRAGMMATIC	Other Identifier	Mayo Clinic
23-006335	Other Identifier	Mayo Clinic Institutional Review Board

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2023Actual

Primary Completion Date

Jun 5, 2025Actual

Completion Date

Jun 5, 2025Actual

First Submitted Date

Nov 22, 2023

First Submission Date that Met QC Criteria

Nov 22, 2023

First Posted Date

Nov 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2025

Last Update Posted Date

Jun 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Patients have their medical records reviewed on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with previously untreated multiple myeloma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaji K. Kumar, MD	Mayo Clinic in Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Arizona		Scottsdale	Arizona	85259	United States
Mayo Clinic in Florida

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided