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

Multiple Myeloma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376883
• Other study ID #: NMSG 08/00
• Secondary ID: NCU D3-98
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2006
• Last updated: January 3, 2007
• Start date: January 2000
• Est. completion date: October 2006

Study information

• Verified date: January 2007
• Source: Nordic Myeloma Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• pamidronate

Locations

Country	Name	City	State
Denmark	Department of Haematology B, Aalborg Hospital, University of Aarhus	Aalborg
Denmark	Hæmatologisk afd., Århus Universitetshospital	Århus
Denmark	Department of Haematology, Herlev University Hospital	Herlev
Denmark	Department of Hematology L, Rigshospitalet	København Ø
Norway	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
Sweden	Sahlgrenska Universitetsjukhuset Östra	Gothenburg
Sweden	Hematologkliniken, Universitetssjukhuset	Linköping
Sweden	Medicinklin, Universitetssjukhuset MAS,	Malmö
Sweden	Medicinkliniken, Universitetssjukhuset	Örebro
Sweden	Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus	Umeå
Sweden	Medicinklinikken Akademiska sjukhuset	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Nordic Myeloma Study Group	Nordic Cancer Union

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire
Secondary	Skeletal related event (time to first SRE)
Secondary	Cost-utility analysis
Secondary	Subgroup analysis (conventional chemotherapy vs. high dose chemotherapy with stem cell support)
Secondary	Response, recons duration, survival
Secondary	Quality of Life estimated by fatigue and pain according to EORTC QLQ-C30