Multiple Myeloma
Conditions
Interventions
Melphalan (6mg/m2) and prednisone (40mg/m2) are given orally for 4 days. MP therapy will be given continuously every 4 weeks unless serious adverse events occur, or the patients meet the criteria as f
1) If CR, PR or MR and plateau-phase are achieved, and plateau phase continue for 3 months, MP therapy will be stopped. After discontinuation of MP therapy, MP therapy will be given again, if M-protei
Sponsors
Myeloma Bone Disease Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed diagnosis of multiple myeloma (symptomatic) according to the IMWG criteria defined as follows: A. M-protein in serum and/or urine B. Bone marrow clonal plasma cells or plasmacytoma C. Related organ or tissue impairment (end organ damage, including bone lesions) 1)Renal insufficiency 2)Anaemia 3)Lytic bone lesions 4)Others: hyperviscosity, amyloidosis, recurrent infections 2. Patients ineligible for autologous stem cell transplantation are defined as: 1) Those impossible to receive high dose chemotherapy 2) Those who do not request transplants 3. Those with at least one osteolytic bone lesion (confirmed by diagnostic imaging with X-ray or CT or MRI) 4. Those with a life expectancy of at least 1 year 5. Those with ECOG performance status: 0-2 (Patients with PS 3 restricted by bone lesions are allowed to participate ) 6. Those with adequate organ function 1)AST, ALT, T-Bil<X2 ULM 2)Ccr>=30 mL/min 7. Those who have given written informed consent.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroshi Handa
Gunma University School of Health Sciences, Faculty of Medicine
Outcome results
None listed