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.
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire
Principal Investigator
Peter Gimsing, Ass. prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Nordic Myeloma Study Group
Authority:
Denmark: Danish Medicines Agency
Study ID:
NMSG 08/00
NCT ID:
NCT00376883
Start Date:
January 2000
Completion Date:
October 2006
Related Keywords:
- Multiple Myeloma
- multiple myeloma
- pamidronate prophylaxis
- dose comparison
- quality of life
- skeletal event
- response
- survival
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|
