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

NCT07689006 | Completed FDA Drug

• 1 other identifier: CA077-1012
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

Multiple Myeloma; Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• Progression-Free Survival (PFS) among participants who initiated pomalidomide-containing index regimens

  Up to 6 years

• Overall Survival (OS) among participants who initiated pomalidomide-containing index regimens

  Up to 6 years

• Overall Response Rate (ORR) among participants who initiated pomalidomide-containing index regimens

  Up to 6 years

• Time to Next Treatment (TTNT) among participants who initiated pomalidomide-containing index regimens

  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

Study Arms (2)

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

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

Interventions

Pomalidomide-containing regimens DRUG

Exposure to pomalidomide-containing index regimens, including daratumumab, pomalidomide, and dexamethasone (DPd) and carfilzomib, pomalidomide, and dexamethasone (KPd), administered in routine clinical practice.

Pomalidomide-containing regimens

Non-pomalidomide-containing regimens DRUG

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.

Non-pomalidomide-containing regimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

OneOncology Network

Nashville, Tennessee, 37219, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: December 23, 2024
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)