Background: Docetaxel has activity against multiple malignancies. In a previous ECOG study of untreated patients with multiple myeloma, paclitaxel was found to have mild activity, but had excessive toxicity. Docetaxel was evaluated in patients with relapsing or refractory multiple myeloma.
Method: Well-documented patients with relapsing or refractory multiple myeloma, who had received no more than two prior combination chemotherapy regimens, were treated with docetaxel 75 mgm(-2) intravenously over 1h every 3 weeks. Patients were evaluated after two and four cycles of treatment. Standard ECOG criteria were used to evaluate for response and toxicity.
Results: The study accrued 31 patients with 28 eligible for response and 30 for toxicity analysis. No objective responses (partial or complete) were found. One patient died due to pneumonia. The majority of patients (80%) developed grade 3-4 granulocytopenia and 23% experienced grade 3-4 thrombocytopenia. The median number of cycles was three. The median survival was 9.9 months.
Conclusion: Docetaxel was inactive in patients with relapsing or refractory multiple myeloma. In addition, at 75 mgm(-2) every 3 weeks, there was extensive hematological toxicity. It is unlikely that a change in dose or a different schedule would significantly improve response, limit toxicity, and improve survival in patients with multiple myeloma.