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| Sponsors and Collaborators: |
Nordic Myeloma Study Group Nordic Cancer Union |
|---|---|
| Information provided by: | Nordic Myeloma Study Group |
| ClinicalTrials.gov Identifier: | NCT00376883 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: pamidronate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
| 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. |
| Estimated Enrollment: | 500 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Hæmatologisk afd., Århus Universitetshospital | |
| Århus, Denmark, DK-8000 | |
| 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 | |
| Norway | |
| Hematologisk avdeling Ullevål Sykehus | |
| Oslo, Norway, N - 0407 | |
| Hematologisk seksjon, med avd, Haukeland Universitetssykehus | |
| Bergen, Norway, N-5021 | |
| Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge | |
| Tromsø, Norway, N-9038 | |
| Hematologisk seksjon, St.Olav Hospital | |
| Trondheim, Norway, N-7006 | |
| Sweden | |
| Medicinklinikken Akademiska sjukhuset | |
| Uppsala, Sweden, SE-751 85 | |
| Hematologkliniken, Universitetssjukhuset | |
| Linköping, Sweden, SE-581 85 | |
| Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus | |
| Umeå, Sweden, SE-901 85 | |
| Sahlgrenska Universitetsjukhuset Östra | |
| Gothenburg, Sweden, SE-416 85 | |
| Medicinkliniken, Universitetssjukhuset | |
| Örebro, Sweden, SE-70185 | |
| Medicinklin, Universitetssjukhuset MAS, | |
| Malmö, Sweden, SE-205 02 | |
| Principal Investigator: | Peter Gimsing, Ass. prof. | Nordic Myeloma Study Group |
More Information
| Study ID Numbers: | NMSG 08/00, NCU D3-98 |
| Study First Received: | September 14, 2006 |
| Last Updated: | January 3, 2007 |
| ClinicalTrials.gov Identifier: | NCT00376883 |
| Health Authority: | Denmark: Danish Medicines Agency |
|
multiple myeloma pamidronate prophylaxis dose comparison quality of life |
skeletal event response survival |
|
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Quality of Life Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Diphosphonates Hemorrhagic Disorders Multiple myeloma Pamidronate Lymphoproliferative Disorders Neoplasms, Plasma Cell |
|
Neoplasms Neoplasms by Histologic Type Immune System Diseases Physiological Effects of Drugs |
Bone Density Conservation Agents Cardiovascular Diseases Pharmacologic Actions |
