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

January 3, 2007 updated by: Nordic Myeloma Study Group

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Myeloma Study Group

Collaborators

Nordic Cancer Union

Investigators

  • Principal Investigator: Peter Gimsing, Ass. prof., Nordic Myeloma Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

September 14, 2006

First Submitted That Met QC Criteria

September 14, 2006

First Posted (Estimate)

September 15, 2006

Study Record Updates

Last Update Posted (Estimate)

January 4, 2007

Last Update Submitted That Met QC Criteria

January 3, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMSG 08/00
  • NCU D3-98

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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