Multiple MyelomaPhase 3NCT00602511
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
A Phase 3 study testing Bortezomib and Thalidomide in people with Multiple Myeloma, run by Nordic Myeloma Study Group at 27 sites in 3 countries.
Trial summary
The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as… 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?
- Bortezomib and Thalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 27 sitesin 3 countries
- Study dates
- Oct 2007to Dec 2010
- 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
- Treatment demanding multiple myeloma
- Refractoriness to melphalan
- Acceptance of rules for prevention of pregnancy
Who cannot join
- Previous treatment with bortezomib, thalidomide, or lenalidomide
- Sensory neuropathy grade III or neuropathic pain grade II
- Severe concomitant disorder, e.g. other malignancy or severe heart disease
- Transformation to plasma cell leukemia or aggressive lymphoma
- Frequent visits for bortezomib injections not feasible
- Anticipated non-adherence to study protocol
Show all 9Show fewer
- Pregnancy
- Anticipated non-adherence to rules for prevention of pregnancy
- Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
Sweden18 sites
Falun Hospital
Falun, 79182
Gävle Hospital
Gävle, 80187
Sahlgrenska University Hospital
Gothenburg, 41345
Helsingborg Hospital
Helsingborg, 25187
Lidköping Hospital
Lidköping, 53185
Lund University Hospital
Lund, 22185
Malmö University Hospital
Malmö, 20502
Mölndal hospital
Mölndal, 43180
Örebro University Hospital
Örebro, 70185
Örnsköldsvik Hospital
Örnsköldsvik, 89189
Skövde Hospital
Skövde, 54185
St Göran Hospital
Stockholm, 11281
Sundsvall Hospital
Sundsvall, 85186
Uddevalla Hospital
Uddevalla, 45180
Norrland University Hospital
Umeå, 90185
Uppsala University Hospital
Uppsala, 75185
Västerås Hospital
Västerås, 72189
Växjö Hospital
Vaxjo, 35185
Denmark5 sites
Ålborg university Hospital
Aalborg, 9000
Århus University Hospital
Aarhus, 8000
Rigshospitalet
Copenhagen, 2100
Herlev University Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
Norway4 sites
Ullevål Sykehus
Oslo, 0407
Diakonhjemmet
Oslo
Stavanger Universitetssykehus
Stavanger, 4068
Trondheim University Hospital
Trondheim, N-7006
About this study
The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.
Read the detailed description
The study is an open randomized multicentre study in which patients with multiple myeloma refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy, in both arms with the addition of dexamethasone. In case of failure to the initially given treatment the patient will be crossed over to the alternative treatment.
The number of patients needed is calculated to 300, based upon the hypothesis of a 50% difference in progression free survival, a significance level of 95% and a power of 80%. With 12 patients being recruited each month during 25 months and a 4 months follow-up after the last included patient, the total study time will be 29 months.
The dose regimens for bortezomib and thalidomide follow general clinical praxis as regards recommendations for optimal dosing in the Nordic countries.
Evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks, thereafter every 6 weeks. Evaluation of efficacy is done according to The International Myeloma Working Group Uniform Response Criteria. Evaluation of toxicity is done by CTCAE grading. Evaluation of quality of life is done by the EORTC QLQ30 questionnaires with the addition of the myeloma specific MY-24 module which are mailed to the patients at predetermined intervals during the study.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib, Thalidomide
- Keywords
- Melfalan refractory multiple myeloma, Multiple myeloma, Relapsing, Refractory, Thalidomide, Bortezomib, Randomized clinical trial
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles
Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity
ThalidomideDrug
Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day
Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bortezomib - dexamethasone Receives: Drug: Bortezomib |
| 2 | Experimental | Thalidomide - dexamethasone Receives: Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Secondary outcomes (7)
Response rate
Response duration
Time to start of other treatment
Toxicity
Quality of life
Response rate after cross-over
Response duration after cross-over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordic Myeloma Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Martin Hjorth, MD, PhD, Principal investigator, Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602511
- Sponsor's protocol ID
- NMSG 17/07
- Other IDs
- EudraCT no. 2007-001292-11
- Status last verified
- Feb 2011
- First submitted
- 15 Jan 2008
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
- ClinicalTrials.gov ID
- NCT00602511
- Acronym / sponsor ID
- NMSG 17/07
- Conditions
- Multiple Myeloma
- Keywords
- Melfalan refractory multiple myeloma, Multiple myeloma, Relapsing, Refractory, Thalidomide, Bortezomib, Randomized clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nordic Myeloma Study GroupUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jan 2008 (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.
The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.
Detailed description
The study is an open randomized multicentre study in which patients with multiple myeloma refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy, in both arms with the addition of dexamethasone. In case of failure to the initially given treatment the patient will be crossed over to the alternative treatment.
The number of patients needed is calculated to 300, based upon the hypothesis of a 50% difference in progression free survival, a significance level of 95% and a power of 80%. With 12 patients being recruited each month during 25 months and a 4 months follow-up after the last included patient, the total study time will be 29 months.
The dose regimens for bortezomib and thalidomide follow general clinical praxis as regards recommendations for optimal dosing in the Nordic countries.
Evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks, thereafter every 6 weeks. Evaluation of efficacy is done according to The International Myeloma Working Group Uniform Response Criteria. Evaluation of toxicity is done by CTCAE grading. Evaluation of quality of life is done by the EORTC QLQ30 questionnaires with the addition of the myeloma specific MY-24 module which are mailed to the patients at predetermined intervals during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: BortezomibBortezomib - dexamethasone |
| 2 | Experimental | Drug: ThalidomideThalidomide - dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Treatment demanding multiple myeloma
- Refractoriness to melphalan
- Acceptance of rules for prevention of pregnancy
Key exclusion criteria (9 listed)
- Previous treatment with bortezomib, thalidomide, or lenalidomide
- Sensory neuropathy grade III or neuropathic pain grade II
- Severe concomitant disorder, e.g. other malignancy or severe heart disease
- Transformation to plasma cell leukemia or aggressive lymphoma
- Frequent visits for bortezomib injections not feasible
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 |
|---|---|---|
| BortezomibBortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity | Drug | 1 |
| ThalidomideThalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity | Drug | 2 |
Primary outcome
Progression free survival
7 secondary outcomes
Response rate
Response duration
Time to start of other treatment
Toxicity
Quality of life
Response rate after cross-over
Response duration after cross-over
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 9 Feb 2011.
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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.
Martin Hjorth, MD, PhD principal investigator
Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden
27 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 Bortezomib and Thalidomide in people with Multiple Myeloma, run by Nordic Myeloma Study Group at 27 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 3 inclusion and 9 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 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
Progression free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2011.