Multiple MyelomaPhase 3NCT00222053
IFM 99-02 Thalidomide in Myeloma
A Phase 3 study testing Thalidomide and Biphosphonates in people with Multiple Myeloma, run by University Hospital, Toulouse at 5 sites in France.
Trial summary
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Thalidomide and Biphosphonates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 5 sitesFrance
- Study dates
- Apr 2000to 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- de novo myeloma
- according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
- patients from 18 to 65 years old
- beta2microglobulin < 3 mg/l or del13 absent
- signed informed consent
- eligible for transplantation
Who cannot join
- peripheral neurological toxicities
- uncontrolled or severe cardiovascular disease
- other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
- patient who received biphosphonate during the last 60 days
- renal failure definited as creatinine > 150 µmol/l
- patient with obvious vascular cerebral medical history
Show all 10Show fewer
- liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N
- respiratory dysfunction
- HIV +
- Patient who refused to use an acceptable barrier method for contraception
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Médecine Interne, CHU Purpan
Toulouse
Médecine Interne, Hôpital Rangueil
Toulouse
Rhumatologie, CHU Purpan
Toulouse
Rhumatologie, CHU Rangueil
Toulouse
Service d'hématologie, CHU Purpan
Toulouse
About this study
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
- Conditions
- Multiple Myeloma
- Being tested
- Thalidomide, Biphosphonates
- Keywords
- Myeloma, Autologous transplantation, Maintenance therapy, Thalidomide
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Per os thalidomide
BiphosphonatesDrug
Biphosphonates
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | No specific intervention |
| 2 | Active comparator | Biphosphonates Receives: Drug: Biphosphonates |
| 3 | Experimental | Thalidomide Receives: Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of response
Measured: 3 years
Secondary outcomes (2)
Survival
Measured: 3 years
Toxicity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2000
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Investigators
- ATTAL Michel, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222053
- Sponsor's protocol ID
- PHRC 98-45-N
- Status last verified
- Apr 2010
- First submitted
- 15 Sep 2005
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.
PubMed 9850028Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
PubMed 8649495
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IFM 99-02 Thalidomide in Myeloma
- ClinicalTrials.gov ID
- NCT00222053
- Acronym / sponsor ID
- PHRC 98-45-N
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Autologous transplantation, Maintenance therapy, Thalidomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Apr 2000
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Sep 2005 (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.
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –No specific intervention |
| 2 | Active comparator | Drug: BiphosphonatesBiphosphonates |
| 3 | Experimental | Drug: ThalidomideThalidomide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- de novo myeloma
- according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
- patients from 18 to 65 years old
- beta2microglobulin < 3 mg/l or del13 absent
- signed informed consent
Key exclusion criteria (10 listed)
- peripheral neurological toxicities
- uncontrolled or severe cardiovascular disease
- other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
- patient who received biphosphonate during the last 60 days
- renal failure definited as creatinine > 150 µmol/l
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 |
|---|---|---|
| ThalidomidePer os thalidomide | Drug | 3 |
| BiphosphonatesBiphosphonates | Drug | 2 |
Primary outcome
Duration of response
Time frame: 3 years
2 secondary outcomes
Survival
Time frame: 3 years
Toxicity
Time frame: 3 years
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 2 Apr 2010.
- Background: PubMed 9850028Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.
- Background: PubMed 8649495Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
Related trials for Multiple Myeloma
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
RecruitingPhase 2
Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1/2
A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1/2
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
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.
ATTAL Michel, MD principal investigator
University Hospital, Toulouse
5 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 and Biphosphonates in people with Multiple Myeloma, run by University Hospital, Toulouse at 5 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 6 inclusion and 10 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 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Duration of response (time frame: 3 years). 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 NCT00222053, which also lists 2 linked publications.
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 2 Apr 2010.