Multiple Myeloma Clinical Trial
Official title:
The Effect of i.v. Bisphosphonate on Health-Related Quality of Life and Skeletal Morbidity for Newly Diagnosed Treatment Demanding Multiple Myeloma. A Prospective Randomised Double Blinded Dose-Effective Study With Cost-Utility Analysis.
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.
Patients with newly diagnosed treatment demanding multiple myeloma are after informed
consent and approved inclusion criteria randomised by telephone call to Copenhagen Trial
Unit (CTU) and information on the target dose is send to the distributor, Amgros, and the
local pharmacy for preparation of the pamidronate solution. Infusion is given for 2½ hours.
Before starting treatment the patient has to fulfil the first EORTC QLQ-C30 questionnaire
that is send to the quality of life secretariat in Oslo, Norway. Subsequent questionnaires
are mailed directly to the patients every third month.
The infusions are continued for 3 years and may be extended further upon the patient’s
request.
Every third month the number of skeletal event, the response and complications are recorded.
Skeletal X-rays are performed 9 and 24 months after starting the treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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