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.
Verified date | January 2007 |
Source | Nordic Myeloma Study Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | October 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Haematology B, Aalborg Hospital, University of Aarhus | Aalborg | |
Denmark | Hæmatologisk afd., Århus Universitetshospital | Århus | |
Denmark | Department of Haematology, Herlev University Hospital | Herlev | |
Denmark | Department of Hematology L, Rigshospitalet | København Ø | |
Norway | Hematologisk seksjon, med avd, Haukeland Universitetssykehus | Bergen | |
Norway | Hematologisk avdeling Ullevål Sykehus | Oslo | |
Norway | Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge | Tromsø | |
Norway | Hematologisk seksjon, St.Olav Hospital | Trondheim | |
Sweden | Sahlgrenska Universitetsjukhuset Östra | Gothenburg | |
Sweden | Hematologkliniken, Universitetssjukhuset | Linköping | |
Sweden | Medicinklin, Universitetssjukhuset MAS, | Malmö | |
Sweden | Medicinkliniken, Universitetssjukhuset | Örebro | |
Sweden | Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus | Umeå | |
Sweden | Medicinklinikken Akademiska sjukhuset | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Nordic Myeloma Study Group | Nordic Cancer Union |
Denmark, Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire | |||
Secondary | Skeletal related event (time to first SRE) | |||
Secondary | Cost-utility analysis | |||
Secondary | Subgroup analysis (conventional chemotherapy vs. high dose chemotherapy with stem cell support) | |||
Secondary | Response, recons duration, survival | |||
Secondary | Quality of Life estimated by fatigue and pain according to EORTC QLQ-C30 |
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