The clinical trial of Thalidomide maintenance therapy for multiple myeloma patients ineligible for hematopoietic stem cell transplantation.
- Conditions
- multiple myeloma
- Registration Number
- JPRN-UMIN000006182
- Lead Sponsor
- Japan Myeloma Expert Network (J-MEN) of Japan Myeloma Network (JMN)
- Brief Summary
A prospective, multicenter, phase II study was performed to assess the efficacy and safety of thalidomide maintenance therapy at different doses in Japanese multiple myeloma (MM) patients. This study included 34 patients (median age, 74 years) who were previously treated with not more than three prior therapies and whose response status was evaluated as at least stable disease. They were randomized into Group A (no maintenance; 12 patients), Group B (50 mg thalidomide maintenance; 12 patients), and Group C (100 mg thalidomide maintenance; 10 patients), respectively. Thalidomide maintenance therapy resulted in improved depth of response in three cases (13.6%) and sustained response after induction therapy in eight cases (36.4%). Two-year progression-free survival (PFS) was 25.0%, 33.3%, and 77.8% in Groups A, B, and C, respectively, and was significantly higher in Group C than in Group A (p = 0.005). There was no difference in the incidence of hematological or non-hematological adverse events between Groups B and C. The current study demonstrates that maintenance with daily thalidomide at 100 mg, but not 50 mg, improved depth of response and prolonged PFS, and that this treatment was feasible for use in Japanese MM patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
(1)continued treatment and/or prior treatment history with thalidomide (2)patients treated with other agents of MM as clinical trials or individual import, before induction treatment. (3)pregnant or nursing women (4)having prior history or current complications of deep vein thrombosis or pulmonary embolism (5)serious or uncontrollable active infection (6)at least HBs-Ag positive or at least HCV-Ab positive, or HIV-Ab positive (7)Organ dysfunction (8)uncontrollable involvement (diabetes mellitus, hypertension) (9)Psychological disturbance: serious disturbance of consciousness, mental illness (schizophrenia, manic depression et al.) (10)Cardiac dysfunction: serious or uncontrollable cardiac dysfunction (11)Respiratory dysfunction: serious or uncontrollable respiratory dysfunction (12)Those who are considered as inappropriate to register by attending physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (2yr-PFS)
- Secondary Outcome Measures
Name Time Method 1. Efficacy 1-1. To assess the overall response rate (ORR) 1-2. To assess the overall survival(OS) 1-3. To assess the progression free survival (PFS) 2. Safety 2-1.laboratory data, vital sign, ECG 2-2. clinical findings 2-3.adverse effect