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

This study has been completed.
Sponsor:
Collaborator:
Nordic Cancer Union
Information provided by:
Nordic Myeloma Study Group
ClinicalTrials.gov Identifier:
NCT00376883
First received: September 14, 2006
Last updated: January 3, 2007
Last verified: January 2007
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: pamidronate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Nordic Myeloma Study Group:

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

Estimated Enrollment: 500
Study Start Date: January 2000
Estimated Study Completion Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376883

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

No publications provided by Nordic Myeloma Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00376883     History of Changes
Other Study ID Numbers: NMSG 08/00, NCU D3-98
Study First Received: September 14, 2006
Last Updated: January 3, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Nordic Myeloma Study Group:
multiple myeloma
pamidronate prophylaxis
dose comparison
quality of life
skeletal event
response
survival

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014