Efficacy and safety of new drugs for induction, autologous stem cell transplantation, and consolidation therapy in elderiy patients with newly diagnosed symptomatic multiple myeloma.
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000010166
- Lead Sponsor
- Fukuoka Blood and Marrow Transplantation Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1) Nonsecretory MM and plasma cell leukemia. 2) Known human immunodeficiency virus (HIV) infection or active hepatitis A, B or C. 3) Serious concurrent uncontrolled medical disorder. (hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction diabetes, hypertension and infectious diseases) 4) Peripheral neuropathy and neuropathic pain >=Grade 2(CTCAE ver.4.0). 5) History of malignant tumors (except for completely resected in situ carcinoma) during the previous 5 years. 6) Severe uncontrolled psychiatric disorder or illness. 7) Pregnant or lactating female 8) History of hypersensitivity to mannitol or boron. 9) Patients with pneumonia, pulmonary fibrosis or bilateral interstitial abnormalities. 10) Prior steroids treatment (allowed if short term treatment for their general condition or reduction the number of cancer cells) 11) Unwillingness or inability to follow the procedures required in the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate: sCR+CR+VGPR rate 100 days after autologous PBSCT
- Secondary Outcome Measures
Name Time Method