Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month

Sponsor

Nordic Myeloma Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00376883

Collaborator

Nordic Cancer Union (Other)

500

Enrollment

Locations

Duration (Months)

35.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: pamidronate	Phase 3

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 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

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.

Study Start Date :

Jan 1, 2000

Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Haematology B, Aalborg Hospital, University of Aarhus	Aalborg	Denmark	9000
2	Department of Haematology, Herlev University Hospital	Herlev	Denmark	2730
3	Department of Hematology L, Rigshospitalet	København Ø	Denmark	DK-2100
4	Hæmatologisk afd., Århus Universitetshospital	Århus	Denmark	DK-8000
5	Hematologisk seksjon, med avd, Haukeland Universitetssykehus	Bergen	Norway	N-5021
6	Hematologisk avdeling Ullevål Sykehus	Oslo	Norway	N - 0407
7	Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge	Tromsø	Norway	N-9038
8	Hematologisk seksjon, St.Olav Hospital	Trondheim	Norway	N-7006
9	Sahlgrenska Universitetsjukhuset Östra	Gothenburg	Sweden	SE-416 85
10	Hematologkliniken, Universitetssjukhuset	Linköping	Sweden	SE-581 85
11	Medicinklin, Universitetssjukhuset MAS,	Malmö	Sweden	SE-205 02
12	Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus	Umeå	Sweden	SE-901 85
13	Medicinklinikken Akademiska sjukhuset	Uppsala	Sweden	SE-751 85
14	Medicinkliniken, Universitetssjukhuset	Örebro	Sweden	SE-70185