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Completed

NCT Number: NCT07689006

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Up to 6 years

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

    Time frame: Up to 6 years

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

    Time frame: Up to 6 years

  4. 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

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.

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