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

NCT ID: NCT00376883

Last Updated: 2007-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2006-10-31

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.

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

pamidronate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordic Cancer Union

OTHER

Sponsor Role: collaborator

Nordic Myeloma Study Group

OTHER

Sponsor Role: lead

Principal Investigators

Peter Gimsing, Ass. prof.

Role: PRINCIPAL_INVESTIGATOR

Nordic Myeloma Study Group

Locations

Department of Haematology B, Aalborg Hospital, University of Aarhus

Aalborg, , Denmark

Hæmatologisk afd., Århus Universitetshospital

Aarhus, , Denmark

Department of Haematology, Herlev University Hospital

Herlev, , Denmark

Department of Hematology L, Rigshospitalet

København Ø, , Denmark

Hematologisk seksjon, med avd, Haukeland Universitetssykehus

Bergen, , Norway

Hematologisk avdeling Ullevål Sykehus

Oslo, , Norway

Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge

Tromsø, , Norway

Hematologisk seksjon, St.Olav Hospital

Trondheim, , Norway

Sahlgrenska Universitetsjukhuset Östra

Gothenburg, , Sweden

Hematologkliniken, Universitetssjukhuset

Linköping, , Sweden

Medicinklin, Universitetssjukhuset MAS,

Malmo, , Sweden

Medicinkliniken, Universitetssjukhuset

Örebro, , Sweden

Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus

Umeå, , Sweden

Medicinklinikken Akademiska sjukhuset

Uppsala, , Sweden

Countries

Denmark; Norway; Sweden

References

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.

Reference Type: DERIVED

PMID: 20863761 (View on PubMed)

Other Identifiers

NCU D3-98

Identifier Type: -

Identifier Source: secondary_id

NMSG 08/00

Identifier Type: -

Identifier Source: org_study_id