Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month
Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
Participant gender:
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.