Overview of Results from the DETERMINATION Trial of RVd plus ASCT for Newly Diagnosed Multiple Myeloma

Opinion
Video

A review of the recent findings from this clinical trial examining lenalidomide, bortezomib and dexamethasone plus autologous stem cell transplant for newly diagnosed multiple myeloma.

Case: A 54-Year-Old Woman with Newly Diagnosed Multiple Myeloma (NDMM)

Clinical Presentation:

  • FH is a 54-year-old woman who presents to her physician with complaints of back pain, fatigue, nausea, constipation, and occasional, but recurring dizziness

Initial Clinical Workup and Diagnosis:

  • Hb 7.0 g/dL
  • Calcium 11.3 mg/dL
  • Creatinine, 1.5 mg/dL
  • Albumin, 3.2 g/dL
  • β2-microglobulin, 6.0 mg/dL
  • LDH 200 U/L
  • Bone marrow biopsy showed monoclonal plasma cells, 22%.
  • Serum monoclonal protein, 5.0 g/dL
  • Serum kappa FLC, 240.0 mg/L
  • FISH: (+) IGH Translocations; none
  • ECOG PS 1
  • AG was diagnosed with R-ISS stage II/R2-ISS stage III IgG-kappa myeloma.
    • CAR T eligible

Treatment:

  • Patient was initiated on daratumumab/bortezomib/ lenalidomide/ dexamethasone (D-VRd) induction therapy prior to receiving ASCT, followed by lenalidomide maintenance therapy.
    • She achieved VGPR post-induction, and
    • Maintained VGPR post-ASCT

This is a video synopsis/summary of a Case-Based Peer Perspectives featuring Douglas Sborov, MD.

The randomized phase 3 DETERMINATION trial investigated the role of autologous stem cell transplant (autoSCT) in newly diagnosed, transplant-eligible patients with multiple myeloma. In the trial, 722 patients were randomly assigned; the nontransplant arm received 3 cycles of lenalidomide, bortezomib, and dexamethasone (RVD) followed by stem cell collection and 5 more cycles of RVD. The transplant arm had 3 cycles of RVD, stem cell collection, autoSCT, and 2 more cycles of RVD. All then received indefinite lenalidomide maintenance. Primary end point was progression-free survival (PFS); secondary end points included response rates, duration of response, time to progression, overall survival, safety, and quality of life. At a median 76-month follow-up, median PFS was improved by 21 months with transplant, but no overall survival benefit was seen. These results showed that some patients may defer early transplant.

At the 2023 American Society of Hematology Annual Meeting and Exposition, an analysis highlighted PFS differences in White patients similar to the intent-to-treat population, but more similar curves in Black patients. Grade 3 or higher hematologic adverse events, overall response rates, and very good partial response rates were similar between races, but Black patients were less likely to achieve complete response or better than White patients. Important differences between these populations warrant further prospective evaluation.

Video synopsis is AI-generated and reviewed by Targeted Oncology® editorial staff.

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