Among patients with symptomatic newly diagnosed multiple myeloma, treatment with a combination of Revlimid® (lenalidomide), Velcade® (bortezomib), and dexamethasone produced a partial response or better in 100% of patients. The results of this Phase I/II clinical trial were published in the journal Blood.
Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.
Velcade and Revlimid have been approved for use in selected patients with multiple myeloma. Velcade is approved for use in patients with newly diagnosed or relapsed myeloma, and Revlimid is approved in combination with dexamethasone for patients who have received at least one prior therapy.
Studies among patients with relapsed myeloma suggest that the combination of Velcade and Revlimid may be effective. To evaluate this combination among patients with newly diagnosed multiple myeloma, researchers conducted a Phase I/II study among 66 patients with symptomatic myeloma. Thirty-five of the patients were enrolled in the Phase II part of the study.
All study participants were treated with a combination of Velcade, Revlimid, and dexamethasone. Forty-two percent of patients underwent autologous stem cell transplantation (ASCT).
- In the Phase II population, 100% of patients experienced at least a partial response to treatment. Fifty-seven percent of patients had a complete or near-complete response.
- 18-month progression-free survival was 75%, and 18-month overall survival was 97%. Progression-free survival was similar among patients who did and did not have a stem cell transplant; this is a preliminary finding based on a small number of patients.
- Common side effects included sensory neuropathy (80% of patients), fatigue (64% of patients), and constipation (61% of patients). There were no deaths due to treatment.
The results of this small study suggest that the combination of Revlimid, Velcade, and dexamethasone may be highly effective among patients with newly diagnosed multiple myeloma. Phase III studies of this combination are underway.
Reference: Richardson RG, Weller E, Lonial S et al. Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma. Blood. 2010;116:679-686.
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