International Journal of Hematology

DOI: 10.1007/s12185-019-02700-3 Pages: 447-457

Report of phase I and II trials of melphalan, prednisolone, and thalidomide triplet combination therapy versus melphalan and prednisolone doublet combination therapy in Japanese patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation

1. Japanese Red Cross Medical Center, Department of Hematology

2. Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Department of Hematology

3. National Hospital Organization Sendai Medical Center, Department of Hematology

4. National Hospital Organization Okayama Medical Center, Department of Hematology

5. Ogaki Municipal Hospital, Department of Hematology

6. Miyagi Cancer Center, Department of Hematology

7. Oami Municipal Hospital, Department of Hematology

8. Gunma University Graduate School of Health Sciences, Department of Laboratory Sciences

9. National Hospital Organization Higashi Nagoya National Hospital, Department of Hematology/Oncology

Correspondence to:
Kenshi Suzuki
Tel: +81-3-3400-1311
Email: ken-suzuki@mtb.biglobe.ne.jp

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Abstract

We conducted a phase I study to determine the recommended dose of thalidomide combined with melphalan plus prednisolone (MPT) and a phase II study evaluating the efficacy and safety of this MPT regimen in transplant-ineligible Japanese patients with untreated multiple myeloma. The recommended dose was determined to be 100 mg/day in the phase I study. In the phase II, randomized, double-blind, parallel-group study, patients were allocated to either MPT (n = 52) or MP (n = 51), with 21 and 29 patients completing the study, respectively. Overall response rate, the primary endpoint, was significantly higher in the MPT [40.4% (21/52 patients), 95% confidence interval (CI) 27.0–54.9%] than in the MP [19.6% (10/51 patients), 95% CI 9.8–33.1%] group (P = 0.022). Time to response was also significantly shorter in the MPT group. Incidences of hematological toxicities were similar in the two groups, suggesting that addition of thalidomide did not increase hematological toxicity. Although incidences of some non-hematological toxicities tended to be higher in the MPT group, the low incidence of ≥ Grade 3 toxicities suggests that MPT therapy was well tolerated. These results support the safety and efficacy of MPT therapy in untreated Japanese multiple myeloma patients.

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