A Phase II, Open-Label Study of Lenalidomide and Dexamethasone Followed by Donor Lymphocyte Infusions in Relapsed Multiple Myeloma Following Upfront Allogeneic Stem Cell Transplant

A Phase II Study on Lenalidomide and Dexamethasone for Relapsed Multiple Myeloma

Background

Allogeneic stem cell transplant is currently the only potential cure for multiple myeloma (MM), but most patients will relapse. This study aimed to explore the effectiveness and safety of lenalidomide and dexamethasone (Len/Dex) followed by donor lymphocyte infusions (DLIs) in patients who relapsed after transplant.

Methods

Eligible patients aged 18-65 with relapsed MM after transplant received:

  • Six cycles of Len/Dex
  • Three doses of DLIs at intervals of 6 weeks

Bone marrow tests were conducted to monitor disease status. The main goal was to measure progression-free survival (PFS) at 2 years after treatment.

Results

A total of 22 patients participated, with 62% having high-risk features. Key findings include:

  • Median follow-up: 5.3 years
  • PFS: 26.5%
  • Overall survival (OS): 69.2%
  • Response rates: 9.1% complete remission, 50% very good partial response
  • Only 18.2% experienced moderate/severe chronic graft-versus-host disease (GVHD)

No unexpected side effects were noted, and a positive link was found between responses to Len/Dex and DLIs.

Conclusions

This study indicates that Len/Dex followed by DLIs is a safe and feasible option for treating relapsed MM after transplant. Future studies may explore stronger induction therapies and higher DLI doses.

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