Real-World Clinical Outcomes in Relapsed/Refractory Multiple Myeloma Treated With Pomalidomide Regimens

June 30, 2026 updated by: Bristol-Myers Squibb

Analysis of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Receiving Pomalidomide-Containing and Non-Pomalidomide-Containing Regimens in the Real World: A OneOncology United States Database Study

This retrospective observational study will use data from the OneOncology United States database to evaluate clinical outcomes in adults with relapsed/refractory multiple myeloma who received pomalidomide-containing or non-pomalidomide-containing treatment as second-line or third-line therapy after prior exposure to lenalidomide and a proteasome inhibitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

341

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37219
        • OneOncology Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with relapsed/refractory multiple myeloma treated in the OneOncology United States database who previously received both a lenalidomide-containing regimen and a proteasome inhibitor and subsequently initiated specified pomalidomide-containing or non-pomalidomide-containing regimens in the second-line or third-line setting.

Description

Inclusion Criteria:

  • Have a diagnosis of multiple myeloma (ICD-9: 203.00; ICD-10: C90.0x, C90)
  • Are ≥18 years of age at the index date
  • Have received a lenalidomide-containing regimen and received a proteasome inhibitor; exposures do not need to occur within the same line of therapy
  • Have received ≥1 subsequent lines of therapy after lenalidomide and proteasome inhibitor exposure

  • Have received one of the following treatment regimens as the subsequent line (index line) after lenalidomide and proteasome inhibitor exposure:

    • Pomalidomide-containing regimens:
  • Daratumumab, pomalidomide, and dexamethasone (DPd)

  • Carfilzomib, pomalidomide, and dexamethasone (KPd)

    • Non-pomalidomide-containing regimens:
  • Daratumumab, lenalidomide, and dexamethasone (DRd; lenalidomide-refractory participants only)
  • Daratumumab, bortezomib, and dexamethasone (DVd)
  • Daratumumab, carfilzomib, and dexamethasone (DKd)

Exclusion Criteria:

  • Have <6 months of follow-up from the index date; participants who died will be included even with <6 months follow-up, but participants who died within 1 month after the index date will be excluded
  • Have <6 months pre-index enrollment

  • Have other primary cancer diagnoses within 1 year pre-index

    • Excluded ICD-10 diagnosis codes: C00.xx-C76.xx, C7A, C80.xx-C88.xx, C91.xx-C96.xx, D00.xx-D09.xx, D37.xx-D47.1x, D47.3x-D49.xx
    • Excluded ICD-9 diagnosis codes: 149.x through 239.x
    • ICD codes 209.4, 209.5, 209.6, 209.7, D47.Z1, D47.Z2, and D3A will not be excluded
  • Received chimeric antigen receptor T-cell therapy or bispecific antibody therapy before index date or as the index line
  • Have ever enrolled in a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pomalidomide-containing regimens
Participants who initiated daratumumab, pomalidomide, and dexamethasone (DPd) or carfilzomib, pomalidomide, and dexamethasone (KPd) index regimens in the 2L or 3L setting after prior exposure to lenalidomide and a proteasome inhibitor.
Drug: Pomalidomide-containing regimens
Exposure to pomalidomide-containing index regimens, including daratumumab, pomalidomide, and dexamethasone (DPd) and carfilzomib, pomalidomide, and dexamethasone (KPd), administered in routine clinical practice.
Non-pomalidomide-containing regimens
Participants who initiated daratumumab, lenalidomide, and dexamethasone (DRd), or daratumumab, bortezomib, and dexamethasone (DVd), or daratumumab, carfilzomib, and dexamethasone (DKd) index regimens in the 2L or 3L setting after prior exposure to lenalidomide and a proteasome inhibitor.
Drug: Non-pomalidomide-containing regimens
Exposure to non-pomalidomide-containing index regimens, including daratumumab, lenalidomide, and dexamethasone (DRd), daratumumab, bortezomib, and dexamethasone (DVd), and daratumumab, carfilzomib, and dexamethasone (DKd), administered in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) among participants who initiated pomalidomide-containing index regimens
Time Frame: Up to 6 years
Up to 6 years
Overall Survival (OS) among participants who initiated pomalidomide-containing index regimens
Time Frame: Up to 6 years
Up to 6 years
Overall Response Rate (ORR) among participants who initiated pomalidomide-containing index regimens
Time Frame: Up to 6 years
Up to 6 years
Time to Next Treatment (TTNT) among participants who initiated pomalidomide-containing index regimens
Time Frame: Up to 6 years
TTNT is defined as the time from initiation of the pomalidomide-containing index regimen to initiation of the next subsequent line of therapy.
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Actual)

March 28, 2025

Study Completion (Actual)

March 28, 2025

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA077-1012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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