Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Multiple myeloma is a malignant hematological disease dominated by monoclonal plasma cells in the bone marrow. Major symptoms are related to the bones due to an increased bone resorption and a decreased bone formation leading to bone pain and increased risk of fractures. The normal osteoclasts are responsible for bone degradation through stimulation from the malignant plasma cells. Bisphosphonates have been shown to inhibit the osteoclast activity but may have serious side-effects due to renal toxicity and the optimal dose have not been established.

In a randomized double blinded design it is aim to compare the standard of monthly injections of 90 mg pamidronate with 30 mg.

The primary end-point is physical function estimated by EORTC QLQ-C30 questionnaire at 12 months after starting the treatment in newly diagnosed treatment demanding multiple myeloma. Secondary end-points are skeletal related events, cost-utility analysis, response, response duration and survival and quality of life with respect to fatigue and pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordic Myeloma Study Group
• Collaborator: Nordic Cancer Union
• Treatments: Pamidronate

Criteria

Inclusion Criteria:

• New diagnosed multiple myeloma with treatment demanding disease

Exclusion Criteria:

• Life-expectancy less than 3 months, another active malignant disease, treatment with bisphosphonates for more than 3 months within the last 6 months, patients with creatinine above 400 µmol/l 4 weeks after starting chemotherapy, patients who cannot cooperate for monthly infusions, patients who do not give their informed consent