Multiple MyelomaPhase 3NCT00376883
Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month
A Phase 3 study testing pamidronate in people with Multiple Myeloma, run by Nordic Myeloma Study Group at 14 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- pamidronate
- How many people
- 500 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Jan 2000to Oct 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosed multiple myeloma with treatment demanding disease
Who cannot join
- 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
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Sweden6 sites
Sahlgrenska Universitetsjukhuset Östra
Gothenburg, SE-416 85
Hematologkliniken, Universitetssjukhuset
Linköping, SE-581 85
Medicinklin, Universitetssjukhuset MAS,
Malmö, SE-205 02
Medicinkliniken, Universitetssjukhuset
Örebro, SE-70185
Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus
Umeå, SE-901 85
Medicinklinikken Akademiska sjukhuset
Uppsala, SE-751 85
Denmark4 sites
Department of Haematology B, Aalborg Hospital, University of Aarhus
Aalborg, 9000
Hæmatologisk afd., Århus Universitetshospital
Aarhus, DK-8000
Department of Haematology, Herlev University Hospital
Herlev, 2730
Department of Hematology L, Rigshospitalet
København Ø, DK-2100
Norway4 sites
Hematologisk seksjon, med avd, Haukeland Universitetssykehus
Bergen, N-5021
Hematologisk avdeling Ullevål Sykehus
Oslo, N - 0407
Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge
Tromsø, N-9038
Hematologisk seksjon, St.Olav Hospital
Trondheim, N-7006
About this study
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.
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.
Read the 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
- Being tested
- pamidronate
- Keywords
- multiple myeloma, pamidronate prophylaxis, dose comparison, quality of life, skeletal event, response, survival
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pamidronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startJan 2000
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Nordic Myeloma Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Cancer Union
- Investigators
- Peter Gimsing, Ass. prof., Principal investigator, Nordic Myeloma Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376883
- Sponsor's protocol ID
- NMSG 08/00
- Other IDs
- NCU D3-98
- Status last verified
- Jan 2007
- First submitted
- 14 Sep 2006
- Last updated
- 4 Jan 2007
- Results posted
- No
Publications
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.
PubMed 20863761
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00376883
- Acronym / sponsor ID
- NMSG 08/00
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, pamidronate prophylaxis, dose comparison, quality of life, skeletal event, response, survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Nordic Myeloma Study GroupUniversity, hospital or other
- Collaborators
- Nordic Cancer Union
- Study start
- Jan 2000
- Study completion
- Oct 2006
- First posted
- 15 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New diagnosed multiple myeloma with treatment demanding disease
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pamidronate | Drug | – |
Primary outcome
Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2007.
- Derived from this study: PubMed 20863761Gimsing 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Gimsing, Ass. prof. principal investigator
Nordic Myeloma Study Group
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pamidronate in people with Multiple Myeloma, run by Nordic Myeloma Study Group at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Sweden, Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00376883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2007.