Newly Diagnosed, Multiple MyelomaPhase 3IFM 01/01NCT00644306
Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
A Phase 3 study testing Thalidomide, melphalan, prednisone and melphalan, prednisone, thalidomide in people with Newly Diagnosed, Multiple Myeloma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Newly Diagnosed, Multiple Myeloma
- What is being tested?
- Thalidomide, melphalan, prednisone and melphalan, prednisone, thalidomide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2002to May 2007
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients.
Who cannot join
- Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
- Primary or associated amyloïdosis
- World Health organisation performance index of at least 3
- Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
- Cardiac or hepatic dysfunction
- Cerebral circulatory insufficiency
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- Absolute contraindication to corticosteroids
- Peripheral neuropathy clinically significant
- History of venous thrombosis during the last 6 months
- HIV or hepatitis B or C positivity
- Patients who had geography, social, or psychological conditions which might prevent adequate follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.
- Conditions
- Newly Diagnosed, Multiple Myeloma
- Being tested
- Thalidomide, melphalan, prednisone, melphalan, prednisone, thalidomide
- Keywords
- Multiple Myeloma, very elderly patients, thalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
100 mg/day continuously for 18 months
melphalan, prednisoneDrug
Also called Alkeran, cortancyl
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
melphalan, prednisone, thalidomideDrug
Also called Alkeran, cortancyl
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months Receives: Drug: Thalidomide; Drug: melphalan, prednisone |
| B | Active comparator | 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months Receives: Drug: melphalan, prednisone, thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall Survival
Measured: May 2007
Secondary outcomes (3)
Progression Free Survival
Measured: May 2007
Response rates
Measured: May 2007
Safety
Measured: May 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startApr 2002
- Study completionMay 2007
Why it stopped: survival advantage demonstrated
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 Newly Diagnosed, Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Investigators
- Cyrille Hulin, MD, Principal investigator, Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644306
- Sponsor's protocol ID
- University Hospital, Nancy
- Acronym
- IFM 01/01
- Status last verified
- Mar 2008
- First submitted
- 20 Mar 2008
- Last updated
- 26 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. doi: 10.1016/S0140-6736(07)61537-2.
PubMed 17920916
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00644306
- Acronym / sponsor ID
- IFM 01/01 / University Hospital, Nancy
- Conditions
- Newly Diagnosed, Multiple Myeloma
- Keywords
- Multiple Myeloma, very elderly patients, thalidomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: survival advantage demonstrated
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- May 2007 (actual)
- First posted
- 26 Mar 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.
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Thalidomide, Drug: melphalan, prednisone12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months |
| B | Active comparator | Drug: melphalan, prednisone, thalidomide12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients.
Key exclusion criteria (11 listed)
- Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
- Primary or associated amyloïdosis
- World Health organisation performance index of at least 3
- Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
- Cardiac or hepatic dysfunction
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 |
|---|---|---|
| Thalidomide100 mg/day continuously for 18 months | Drug | A |
| melphalan, prednisoneAlso: Alkeran, cortancyl12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months | Drug | A |
| melphalan, prednisone, thalidomideAlso: Alkeran, cortancyl12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months | Drug | B |
Primary outcome
overall Survival
Time frame: May 2007
3 secondary outcomes
Progression Free Survival
Time frame: May 2007
Response rates
Time frame: May 2007
Safety
Time frame: May 2007
Results and safety
The study was stopped early (reason given: survival advantage demonstrated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2008.
- Background: PubMed 17920916Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. doi: 10.1016/S0140-6736(07)61537-2.
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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.
Cyrille Hulin, MD principal investigator
Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thalidomide, melphalan, prednisone and melphalan, prednisone, thalidomide in people with Newly Diagnosed, Multiple Myeloma, run by Central Hospital, Nancy, France at 1 site in France.
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 11 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: stopped early, as of the sponsor's last update on 26 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: survival advantage demonstrated). Results are not available in the source record.
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?
overall Survival (time frame: May 2007). 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 NCT00644306, 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 26 Mar 2008.