Multiple Myeloma de Novo TreatmentPhase 3MAG 2002NCT01070862
Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies.
A Phase 3 study testing Thalidomide, Dexamethasone, Vincristin , Adriamycin, Dexamethasone = VAD and Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal) in people with Multiple Myeloma de Novo Treatment, run by University Hospital, Caen at 3 sites in France.
Trial summary
The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone before autotransplant, and in elderly patients in combination with conventional chemotherapy and as consolidation/maintenance therapy in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma de Novo Treatment
- What is being tested?
- Thalidomide, Dexamethasone, Vincristin , Adriamycin, Dexamethasone = VAD and Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 3 sitesFrance
- Study dates
- May 2003to Dec 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- for MY-TAG(auto-transplant): age 18-65, multiple myeloma Salmon-Durie stage II, stage III and symptomatic stage I (lytic bone lesion or a 25 % increase of monoclonal protein)
- for MY-DECT (conventional chemotherapy) : qge 66-80, multiple myeloma Salmon-Durie stage II, stage III and symptomatic stage I (lytic bone lesion or a 25 % increase of monoclonal protein)
- for MY-PLAT (maintenance at plateau-phase): patients treated in MY-TAG or MY-DECt with at least a minimal response (25 % decrease of M protein)3-6 months after autotransplant or last chemotherapy
Who cannot join
- for MY-TAG : age 66 or more, smoldering stage I multiple myeloma, previous therapy, plasma cell leukemia,creatinine > 300 micromol/L, liver failure, anthracycline contra-indicated, thalidomide contra-indicated, corticosteroid contra-indicated
- for MY-DECT : age < 66 or > 80, smoldering stage I multiple myeloma, previous therapy, plasma cell leukemia,creatinine > 300 micromol/L, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated
- for MY-PLAT : no response or progressive disease, randomization > 6 m since autotransplant or last chemotherapy, creatinine > 300 micromol/L, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU CAEN Dept of Hematology
Caen, 14033
CHU Henri Mondor
Créteil, 94010
CHU Saint Louis Dept of Hematology
Paris, 75475
About this study
Official title: Multiple Myeloma Treatment With Thalidomide. Three Randomized Studies on Thalidomide as Induction Treatment Before Autotransplant (MY-TAG) or With a Conventional Chemotherapy (MY-DECT) and as Consolidation/Maintenance at Plateau Phase (MY-PLAT).
The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone before autotransplant, and in elderly patients in combination with conventional chemotherapy and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.
Read the detailed description
MY-TAG : Thalidomide as induction treatment before high dose therapy, in young patients MY-DECT : Thalidomide as induction treatment with conventional chemotherapy, in elderly patients MY-PLAT : Thalidomide and Dexamethasone at plateau-phase, after high dose therapy or conventional chemotherapy
- Conditions
- Multiple Myeloma de Novo Treatment
- Being tested
- Thalidomide, Dexamethasone, Vincristin , Adriamycin, Dexamethasone = VAD, Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal), melphalan, endoxan, dexamethasone (MCDex)
- Keywords
- multiple myeloma, treatment, first line
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide, DexamethasoneDrug
Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles
Vincristin , Adriamycin, Dexamethasone = VADDrug
Vincristin 0.4 mg/d continUous IV infusion D1-D4, Adriamycin 9 mg/m2 continuous IV infusion D1-D4, Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle
Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal)Drug
Thalidomide : 200 mg/d at bedtime for 3 months , melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles
melphalan, endoxan, dexamethasone (MCDex)Drug
melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles
Thalidomide, DexamethasoneDrug
Thalidomide 200 mg/d on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94
| Study group | Role | What they receive |
|---|---|---|
| thalidomide + dexamethasone | Experimental | Thalidomide 200 mg/d at bedtime + Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle Receives: Drug: Thalidomide, Dexamethasone |
| Vincristin, Adriamycin, Dexamethasone | Active comparator | Not described Receives: Drug: Vincristin , Adriamycin, Dexamethasone = VAD |
| thalidomide, melphalan, endoxan, dexamethasone | Experimental | Not described Receives: Drug: Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal) |
| melphalan, endoxan, dexamethasone (MCDex) | Active comparator | Not described Receives: Drug: melphalan, endoxan, dexamethasone (MCDex) |
| Thalidomide, Dexamethasone | Experimental | Not described Receives: Drug: Thalidomide, Dexamethasone |
| watch and wait | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
very good partial response rate (monclonal protein decrease of 90 % or more)at the end induction phase (MY-TAG and MY-DECT), progression free survival during consolidation/maintenance treatment (MY-PLAT)
Measured: before autotransplant (MY-TAG), after 4 cycles (MY-DECT), every 6 months (MY-PLAT)
Secondary outcomes (1)
partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startMay 2003
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma de Novo TreatmentStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- None (open label)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Laphal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070862
- Sponsor's protocol ID
- 020879
- Acronym
- MAG 2002
- Status last verified
- Feb 2010
- First submitted
- 17 Feb 2010
- Last updated
- 18 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Myeloma Treatment With Thalidomide. Three Randomized Studies on Thalidomide as Induction Treatment Before Autotransplant (MY-TAG) or With a Conventional Chemotherapy (MY-DECT) and as Consolidation/Maintenance at Plateau Phase (MY-PLAT).
- ClinicalTrials.gov ID
- NCT01070862
- Acronym / sponsor ID
- MAG 2002 / 020879
- Conditions
- Multiple Myeloma de Novo Treatment
- Keywords
- multiple myeloma, treatment, first line
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Laphal
- Study start
- May 2003
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Feb 2010 (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 aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone before autotransplant, and in elderly patients in combination with conventional chemotherapy and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.
Detailed description
MY-TAG : Thalidomide as induction treatment before high dose therapy, in young patients MY-DECT : Thalidomide as induction treatment with conventional chemotherapy, in elderly patients MY-PLAT : Thalidomide and Dexamethasone at plateau-phase, after high dose therapy or conventional chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| thalidomide + dexamethasone | Experimental | Drug: Thalidomide, DexamethasoneThalidomide 200 mg/d at bedtime + Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle |
| Vincristin, Adriamycin, Dexamethasone | Active comparator | Drug: Vincristin , Adriamycin, Dexamethasone = VAD |
| thalidomide, melphalan, endoxan, dexamethasone | Experimental | Drug: Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal) |
| melphalan, endoxan, dexamethasone (MCDex) | Active comparator | Drug: melphalan, endoxan, dexamethasone (MCDex) |
| Thalidomide, Dexamethasone | Experimental | Drug: Thalidomide, Dexamethasone |
| watch and wait | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- for MY-TAG(auto-transplant): age 18-65, multiple myeloma Salmon-Durie stage II, stage III and symptomatic stage I (lytic bone lesion or a 25 % increase of monoclonal protein)
- for MY-DECT (conventional chemotherapy) : qge 66-80, multiple myeloma Salmon-Durie stage II, stage III and symptomatic stage I (lytic bone lesion or a 25 % increase of monoclonal protein)
- for MY-PLAT (maintenance at plateau-phase): patients treated in MY-TAG or MY-DECt with at least a minimal response (25 % decrease of M protein)3-6 months after autotransplant or last chemotherapy
Key exclusion criteria (3 listed)
- for MY-TAG : age 66 or more, smoldering stage I multiple myeloma, previous therapy, plasma cell leukemia,creatinine > 300 micromol/L, liver failure, anthracycline contra-indicated, thalidomide contra-indicated, corticosteroid contra-indicated
- for MY-DECT : age < 66 or > 80, smoldering stage I multiple myeloma, previous therapy, plasma cell leukemia,creatinine > 300 micromol/L, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated
- for MY-PLAT : no response or progressive disease, randomization > 6 m since autotransplant or last chemotherapy, creatinine > 300 micromol/L, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated
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 |
|---|---|---|
| Thalidomide, DexamethasoneThalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles | Drug | thalidomide + dexamethasone |
| Vincristin , Adriamycin, Dexamethasone = VADVincristin 0.4 mg/d continUous IV infusion D1-D4, Adriamycin 9 mg/m2 continuous IV infusion D1-D4, Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle | Drug | Vincristin, Adriamycin, Dexamethasone |
| Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal)Thalidomide : 200 mg/d at bedtime for 3 months , melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles | Drug | thalidomide, melphalan, endoxan, dexamethasone |
| melphalan, endoxan, dexamethasone (MCDex)melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles | Drug | melphalan, endoxan, dexamethasone (MCDex) |
| Thalidomide, DexamethasoneThalidomide 200 mg/d on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94 | Drug | Thalidomide, Dexamethasone |
Primary outcome
very good partial response rate (monclonal protein decrease of 90 % or more)at the end induction phase (MY-TAG and MY-DECT), progression free survival during consolidation/maintenance treatment (MY-PLAT)
Time frame: before autotransplant (MY-TAG), after 4 cycles (MY-DECT), every 6 months (MY-PLAT)
1 secondary outcome
partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy
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 18 Feb 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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, Dexamethasone, Vincristin , Adriamycin, Dexamethasone = VAD and Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal) in people with Multiple Myeloma de Novo Treatment, run by University Hospital, Caen at 3 sites 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 3 inclusion and 3 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 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
very good partial response rate (monclonal protein decrease of 90 % or more)at the end induction phase (MY-TAG and MY-DECT), progression free survival during consolidation/maintenance treatment (MY-PLAT) (time frame: before autotransplant (MY-TAG), after 4 cycles (MY-DECT), every 6 months (MY-PLAT)). 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 18 Feb 2010.