Results of a Multi-Center Randomized Phase II Trial of Thalidomide and Prednisone Maintenance Therapy for Multiple Myeloma Following Autologous Stem Cell Transplant.

摘要: Multiple myeloma (MM) patients benefit from high dose chemotherapy, however relapse is inevitable and novel means of maintaining remission are required. Although oral thalidomide an attractive agent for maintenance studies no careful finding have been performed in this setting. Given uncertainties about the long-term tolerability appropriate therapeutically active situation, we completed a prospective multi-center, randomized phase II trial to assess combined prednisone MM select preferred eventually test III Enrolment was July 2000 September 2001. Eligibility required administration melphalan 200mg/m2 with blood stem cell support within one year treatment onset initiation 60–100 days post infusion. All received 50mg p.o. on alternate at starting 200mg escalating target either or 400mg daily. The primary endpoint incidence dropout reduction due toxicity 6 months. Because excess - related toxicity, entry 400 mg arm closed after completing first stage projected sample size. Sixty Seven were enrolled. Median follow-up 36.8 reached by 31% 64% arm. Allowing reduction, 76% assigned 41% remained any therapy 18 months registration. median cumulative 83.5g (range 16–1626g) arm, while it 76.9g 66–3520g) Thus, higher cumulatively less drug overall as consequence toxicity. Eighty eight percent all reduced 72% 2 years beginning maintenance. Using EBMT response criteria 15% study had attained complete near post-transplantation. During follow up, best achieved upgraded 53% evaluable 38% assessed achieving entry. time start registration 9.9 Progression free survival transplant 32.3 (42.2 PFS therapy). Seventeen 67 died August 2004; 91%.Only met our definition tolerable defined reductions discontinuation least 65% minimum A Phase now testing regimen versus placebo.