Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376883
Status:
COMPLETED
Last Update Posted:
2007-01-04
First Post:
2006-09-14
Brief Title:
Pamidronate Prophylaxis in Multiple Myeloma 30 mgMonth Versus 90 mgMonth
Sponsor:
Nordic Myeloma Study Group
Organization:
Nordic Myeloma Study Group
Study Overview
Official Title:
The Effect of iv 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
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCU D3-98 | None | None | None |