NCT06151717

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

1.7 years

First QC Date

November 22, 2023

Last Update Submit

June 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Observational

Patients have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-interventional study

Observational

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with previously untreated multiple myeloma

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Shaji K. Kumar, MD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2023

First Posted

November 30, 2023

Study Start

September 21, 2023

Primary Completion

June 5, 2025

Study Completion

June 5, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations