Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|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.|
- Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire
- Skeletal related event (time to first SRE)
- Cost-utility analysis
- Subgroup analysis (conventional chemotherapy vs. high dose chemotherapy with stem cell support)
- Response, recons duration, survival
- Quality of Life estimated by fatigue and pain according to EORTC QLQ-C30
|Study Start Date:||January 2000|
|Estimated Study Completion Date:||October 2006|
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.
|Department of Haematology B, Aalborg Hospital, University of Aarhus|
|Aalborg, Denmark, 9000|
|Department of Haematology, Herlev University Hospital|
|Herlev, Denmark, 2730|
|Department of Hematology L, Rigshospitalet|
|København Ø, Denmark, DK-2100|
|Hæmatologisk afd., Århus Universitetshospital|
|Århus, Denmark, DK-8000|
|Hematologisk seksjon, med avd, Haukeland Universitetssykehus|
|Bergen, Norway, N-5021|
|Hematologisk avdeling Ullevål Sykehus|
|Oslo, Norway, N - 0407|
|Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge|
|Tromsø, Norway, N-9038|
|Hematologisk seksjon, St.Olav Hospital|
|Trondheim, Norway, N-7006|
|Sahlgrenska Universitetsjukhuset Östra|
|Gothenburg, Sweden, SE-416 85|
|Linköping, Sweden, SE-581 85|
|Medicinklin, Universitetssjukhuset MAS,|
|Malmö, Sweden, SE-205 02|
|Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus|
|Umeå, Sweden, SE-901 85|
|Medicinklinikken Akademiska sjukhuset|
|Uppsala, Sweden, SE-751 85|
|Örebro, Sweden, SE-70185|
|Principal Investigator:||Peter Gimsing, Ass. prof.||Nordic Myeloma Study Group|