Lenalidomide, Bortezomib, and Dexamethasone Induction and Consolidation Effective in Multiple Myeloma in French Phase II Trial
In a phase II Intergroupe Francophone du Myélome (IFM) trial reported in the Journal of Clinical Oncology by Roussel et al, induction and consolidation treatment with RVD (lenalidomide [Revlimid], bortezomib [Velcade], and dexamethasone) followed by lenalidomide maintenance was associated with a high response rate and favorable tolerability in patients with multiple myeloma.
In the study, 31 symptomatic previously untreated transplantation-eligible patients with multiple myeloma aged < 65 years received three RVD induction cycles followed by cyclophosphamide harvest and autologous stem cell transplantation. Patients then received two RVD consolidation cycles and 1 year of lenalidomide maintenance therapy.
Responses
At least a very good partial response was achieved in 58% of patients at completion of induction therapy, 70% after transplantation, and 87% after consolidation therapy. Maintenance lenalidomide resulted in upgrade of response in 27% of patients. Complete response was achieved in 58% of patients, and 68% had minimal residual disease–negative status on flow cytometry. After a median follow-up of 39 months, estimated 3-year progression-free survival was 77% and 3-year overall survival was 100%. No relapses occurred in patients achieving minimal residual disease–negative status.
Toxicity Profile
The most common toxicities with RVD were neurologic and hematologic, including grade 1 or 2 sensory neuropathy in 55% of patients and grade 3 or 4 neutropenia in 35%, thrombocytopenia in 13%, and anemia in 3%. Overall, grade 3 or 4 adverse events occurred in 74% of patients and serious adverse events occurred in 55%. No grade 3 or 4 neuropathy was observed, with neuropathic pain occurring in 10% of patients.
During lenalidomide maintenance, toxicities were mainly hematologic, including grade 3 or 4 neutropenia (60%), thrombocytopenia (3%), and pancytopenia (3%). No febrile neutropenia was observed, but 81% of patients had grade 1 or 2 infection (primarily upper respiratory tract or lung). Five patients had herpes zoster infection. Two female patients had solid second primary malignancies during follow-up, one with breast cancer and two with recurrent basal cell carcinoma. No treatment-related mortality was observed.
The investigators concluded, “The transplantation program with RVD induction and consolidation followed by lenalidomide maintenance produced high-quality responses and showed favorable tolerability in patients with newly diagnosed [multiple myeloma]. Overall, 68% of patients achieved [minimal residual disease] negativity; none of these patients relapsed. This program is being evaluated in the ongoing IFM/Dana-Farber Cancer Institute 2009 phase III study.”
Murielle Roussel, MD, of Hôpitaux de Toulouse, is the corresponding author for the Journal of Clinical Oncology article.
The study was supported by Janssen Pharmaceuticals and Celgene. For full disclosures of the study authors, visit jco.ascopubs.org.
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