Combination therapy of melphalan plus prednisolone and zoledronic acid for untreated multiple myeloma patients ineligible for autologous stem cell transplantation

UMIN ID: UMIN000001435

Registered date:17/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 2008/10/01
• Target sample size: 130
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 follows; 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-protein increase. 2) The efficacy at 12 week is NC or PD, MP therapy will be discontinued and changed to appropriate chemotherapy. Zoledronic acid is administered intravenously over 15 minutes at the dose of 4mg or an adjusted dose based on renal function every 4 weeks for 2 years.( 26 times infusion for 100 weeks )

Outcome(s)

• Primary Outcome: 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: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Myeloma Bone Disease Study Group
• Source(s) of Monetary Support: None