Combination therapy of melphalan plus prednisolone and zoledronic acid for untreated multiple myeloma patients ineligible for autologous stem cell transplantatio
Phase 2
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-UMIN000001435
- Lead Sponsor
- Myeloma Bone Disease Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with prior treatment with intravenous bisphosphonate 2)Those with previous or concomitant malignancy 3)Those with uncontrolled complications or infectious diseases 4)Those with severe cardiac dysfunction( NYHA classification: 3-4) 5)Those who are pregnant or breast-feeding or potential 6)Those who have current active dental problems including infection of the teeth or jawbone. Recent or planned dental or jaw surgery(e.g. extraction, implants) 7)Those known to have active Hepatitis B or C Viral Infection ( HBs(+) or HCV(+) ) 8)Patients participating other clinical studies 9)Those who are inadequate to be enrolled in the protocol study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients experiencing skeletal-related events (SRE, defined as a pathologic fracture, radiation therapy to bone, surgery to bone, spinal cord compression, hypercalcemia) for 48 weeks.
- Secondary Outcome Measures
Name Time Method 1) The proportion of patients experiencing SRE for 104 weeks 2) Response rate (CR+PR) of the combination of MP and zoledronic acid at 48 weeks 3) The changes in serum markers of bone turnover (serum NTX and BSAP) 4) The changes in lumber spine BMD (L2-L4) 5) Frequency of adverse events