Maintenance lenalidomide after allogeneic HSCT improved response in high-risk multiple myeloma

Maintenance lenalidomide after allogeneic hematopoietic stem cell transplantation was associated with greater overall response but increased acute graft-versus-host disease among patients with high-risk multiple myeloma, according to study results.

Melissa Alsina, MD, of the department of blood and marrow transplantation at H. Lee Moffitt Cancer Center and Research Institute, sought to evaluate whether maintenance lenalidomide (Revlimid, Celgene) would reduce the rate of progression after allogeneic hematopoietic stem cell transplantation (HSCT).

The analysis included 30 patients (median age, 54 years) with high-risk multiple myeloma.

Patients received lenalidomide on days 1 to 21 of 28-day cycles for a maximum of 12 cycles. The median time from HSCT to maintenance therapy was 96 days (range, 66-171), and the most common dose of lenalidomide was 10 mg daily (44%).

Eleven patients (37%) completed 12 cycles of lenalidomide maintenance. The most common reasons for maintenance therapy discontinuation were acute graft-versus-host disease (GVHD; 37%), disease progression (37%), neutropenia (11%), patient withdrawal (5%), infection (5%), skin rash (5%) and fever (5%).

Fourteen patients (47%) experienced acute GVHD after receiving lenalidomide, and the cumulative incidence of grade III to grade IV acute GVHD was 17% (95% CI, 6-32).

Eleven percent of patients (95% CI, 2-24) experienced transplantation-related mortality within 18 months of lenalidomide initiation.

Maintenance lenalidomide was associated with a 33% improvement in overall response. Eighteen-month PFS was 63% (95% CI, 43-77) and 18-month OS was 78% (95% CI, 58-90).

“Given the positive effects on disease control, … the low transplantation-related mortality and the manageable non-GVHD toxicity, we conclude that lenalidomide use can be considered, particularly in patients with high-risk multiple myeloma,” Alsina and colleagues concluded. “Patients can be treated with low doses without escalation and they can be monitored closely for development of GVHD. The survival outcomes observed in this study suggest an important role for maintenance therapy post allogeneic HSCT.”

Paul Richardson

The results support future evaluation of maintenance therapy after transplantation, Paul Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center of the Dana-Farber Cancer Institute and HemOnc Today’s section editor for myeloma, wrote in an accompanying editorial.

“Maintenance strategies incorporating proteasome inhibition have been associated with improved outcomes, and bortezomib (Velcade, Millennium Pharmaceuticals) currently provides an exciting opportunity for more selective antimyeloma effect with less acute GVHD, so providing a strong rationale for using proteasome inhibition as a maintenance strategy either alone or in combination,” Richardson wrote. “Prospective studies of this particular approach and using oral proteasome inhibitors are, therefore, planned by a unified team of investigators across various groups in the United States, including the Alliance and the Clinical Trials Network.”

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Disclosure: The study was funded by Celgene. The researchers report honoraria from and speaker/consultant roles with Celgene. Richardson reports research funding from and advisory roles with Celgene, Janssen and Millennium.