Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month
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.
2 other identifiers
interventional
500
3 countries
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-myeloma
Started Jan 2000
Typical duration for phase_3 multiple-myeloma
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 14, 2006
CompletedFirst Posted
Study publicly available on registry
September 15, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedJanuary 4, 2007
January 1, 2007
September 14, 2006
January 3, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- New diagnosed multiple myeloma with treatment demanding disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nordic Myeloma Study Grouplead
- Nordic Cancer Unioncollaborator
Study Sites (14)
Department of Haematology B, Aalborg Hospital, University of Aarhus
Aalborg, 9000, Denmark
Hæmatologisk afd., Århus Universitetshospital
Aarhus, DK-8000, Denmark
Department of Haematology, Herlev University Hospital
Herlev, 2730, Denmark
Department of Hematology L, Rigshospitalet
København Ø, DK-2100, Denmark
Hematologisk seksjon, med avd, Haukeland Universitetssykehus
Bergen, N-5021, Norway
Hematologisk avdeling Ullevål Sykehus
Oslo, N - 0407, Norway
Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge
Tromsø, N-9038, Norway
Hematologisk seksjon, St.Olav Hospital
Trondheim, N-7006, Norway
Sahlgrenska Universitetsjukhuset Östra
Gothenburg, SE-416 85, Sweden
Hematologkliniken, Universitetssjukhuset
Linköping, SE-581 85, Sweden
Medicinklin, Universitetssjukhuset MAS,
Malmo, SE-205 02, Sweden
Medicinkliniken, Universitetssjukhuset
Örebro, SE-70185, Sweden
Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus
Umeå, SE-901 85, Sweden
Medicinklinikken Akademiska sjukhuset
Uppsala, SE-751 85, Sweden
Related Publications (1)
Gimsing P, Carlson K, Turesson I, Fayers P, Waage A, Vangsted A, Mylin A, Gluud C, Juliusson G, Gregersen H, Hjorth-Hansen H, Nesthus I, Dahl IM, Westin J, Nielsen JL, Knudsen LM, Ahlberg L, Hjorth M, Abildgaard N, Andersen NF, Linder O, Wisloff F. Effect of pamidronate 30 mg versus 90 mg on physical function in patients with newly diagnosed multiple myeloma (Nordic Myeloma Study Group): a double-blind, randomised controlled trial. Lancet Oncol. 2010 Oct;11(10):973-82. doi: 10.1016/S1470-2045(10)70198-4.
PMID: 20863761DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Gimsing, Ass. prof.
Nordic Myeloma Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2006
First Posted
September 15, 2006
Study Start
January 1, 2000
Study Completion
October 1, 2006
Last Updated
January 4, 2007
Record last verified: 2007-01