MyelomaNCT00907452
Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
A study testing melphalan-prednisone-thalidomide and lenalidomide-dexamethasone in people with Myeloma, run by Intergroupe Francophone du Myelome at 26 sites in France.
Trial summary
This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- melphalan-prednisone-thalidomide and lenalidomide-dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 26 sitesFrance
- Study dates
- 29 Jul 2009to 14 Jul 2016
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent form
- Age ≥ 65 years at the time of signing consent
- Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: MM diagnostic criteria (all 3 required)
- Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
- Monoclonal protein present in the serum and/or urine
- Myeloma-related organ dysfunction (at least one of the following):
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- Calcium elevation in the blood (serum calcium > 10.5 mg/l or upper limit of normal)
- Renal insufficiency (serum creatinine > 2 mg/dl)
- Anemia (hemoglobin < 10 g/dl or 2 g < normal)
- Lytic bone lesions or osteoporosis
- have measurable disease by protein electrophoresis analyses as defined by the following:
- IgG multiple myeloma: Serum monoclonal paraprotein (M-protein)level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 h
- IgA multiple myeloma: Serum M-protein level ³ 0.5 mg/dL or urine M-protein level³ 200 mg/24 h
- IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dL or urine Mprotein level ≥ 200 mg/24h
- IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dL or urine M-protein level ≥ 200 mg/24h
- Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dL or urine Mprotein level ≥ 200 mg/24 hours
- ECOG performance status of 0, 1, or 2
- Treated by either melphalan-prednisone-thalidomide or lenalidomide- dexamethasone
Who cannot join
- Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days (4 weeks) of randomization]
- Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study
- Any of the following laboratory abnormalities :
- Absolute neutrophil count (ANC) < 1,000 cells/µL (1.0 x 109/L)
- Platelet count < 50,000 cells/µL (50 x 109/L) for patients in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count < 30,000/µL for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells
- Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
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- Creatinine clearance ≤ 30 mL/min (Cockroft-Gault calculation)
- Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- Patients who have are unable or unwilling to undergo antithrombotic therapy
- Peripheral neuropathy of > grade 2 severity
- Known HIV positivity or active infectious hepatitis, type A, B, or C.
- Primary AL amyloidosis and myeloma complicated by amyloidosis.
- Renal failure requiring dialysis
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
CH ALBI
Albi
CHRU Angers
Angers
CH Côte basque
Bayonne
CH Blois
Blois
BORDEAUX
Bordeaux
Chalon sur Saone
Chalon-sur-Saône
CHU Dijon
Dijon
Ch Dunkerque
Dunkirk
Chu Grenoble
Grenoble
CHD Vendée
La Roche-sur-Yon
CHRU Lille
Lille
CHU LYON
Lyon
LYON SUD
Lyon
Ipc Marseille
Marseille
CHR METZ
Metz
CH Mulhouse
Mulhouse
Chu Nancy
Nancy
Chu Nantes
Nantes
Centre Antoine LACASSAGNE
Nice
Institut Curie
Paris
Chu Poitiers
Poitiers
Chu Rennes
Rennes
CH Yves Le Foll
Saint-Brieuc
René Huguenin
Saint-Cloud
Chu Toulouse
Toulouse
Chu Tours
Tours
About this study
Official title: Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. The goal is to be able to identify patients who will best respond to the study treatments or experience the fewest associated side effects and improve prognosis, in order to optimize care management in multiple myeloma.
To this end, the study seeks to predict the following parameters in these patients:
Read more
- The treatment response and occurrence of adverse events linked to a lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide combination.
- Progression-free survival and overall survival.
Prediction of the treatment response and the occurrence of adverse effects will be based on:
- An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and DNA copy number variations.
- An analysis of changes in the tumor's genotype (change in the DNA copy number) and phenotype (altered gene and micro-RNA expression).
Prediction of progression-free survival and overall survival will be based on an analysis of changes in the tumor's genotype and phenotype.
- Conditions
- Myeloma
- Being tested
- melphalan-prednisone-thalidomide, lenalidomide-dexamethasone
- Keywords
- Pharmacogenomics, prediction response, prediction adverse event
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melphalan-prednisone-thalidomideDrug
lenalidomide-dexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| melphalan-prednisone-thalidomide | Active comparator | Not described Receives: Drug: melphalan-prednisone-thalidomide |
| lenalidomide-dexamethasone | Active comparator | Not described Receives: Drug: lenalidomide-dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
best response to treatment
best response rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study start29 Jul 2009
- Primary completion14 Dec 2010
- Study completion14 Jul 2016
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 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone du Myelome
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Philippe MOREAU, Pr, Study chair, Departement of clinical Hematology (University Hospital of Nantes)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907452
- Sponsor's protocol ID
- IFM 2007-03
- Other IDs
- Eudract: 2008-003486-58
- Status last verified
- Mar 2021
- First submitted
- 20 May 2009
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Miannay B, Minvielle S, Roux O, Drouin P, Avet-Loiseau H, Guerin-Charbonnel C, Gouraud W, Attal M, Facon T, Munshi NC, Moreau P, Campion L, Magrangeas F, Guziolowski C. Logic programming reveals alteration of key transcription factors in multiple myeloma. Sci Rep. 2017 Aug 23;7(1):9257. doi: 10.1038/s41598-017-09378-9.
PubMed 28835615
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
- ClinicalTrials.gov ID
- NCT00907452
- Acronym / sponsor ID
- IFM 2007-03
- Conditions
- Myeloma
- Keywords
- Pharmacogenomics, prediction response, prediction adverse event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Intergroupe Francophone du MyelomeResearch network
- Study start
- 29 Jul 2009 (actual)
- Primary completion
- 14 Dec 2010 (actual)
- Study completion
- 14 Jul 2016 (actual)
- First posted
- 22 May 2009 (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.
This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. The goal is to be able to identify patients who will best respond to the study treatments or experience the fewest associated side effects and improve prognosis, in order to optimize care management in multiple myeloma.
To this end, the study seeks to predict the following parameters in these patients:
- The treatment response and occurrence of adverse events linked to a lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide combination.
- Progression-free survival and overall survival.
Prediction of the treatment response and the occurrence of adverse effects will be based on:
- An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and DNA copy number variations.
- An analysis of changes in the tumor's genotype (change in the DNA copy number) and phenotype (altered gene and micro-RNA expression).
Prediction of progression-free survival and overall survival will be based on an analysis of changes in the tumor's genotype and phenotype.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melphalan-prednisone-thalidomide | Active comparator | Drug: melphalan-prednisone-thalidomide |
| lenalidomide-dexamethasone | Active comparator | Drug: lenalidomide-dexamethasone |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (18 listed)
- Understand and voluntarily sign an informed consent form
- Age ≥ 65 years at the time of signing consent
- Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: MM diagnostic criteria (all 3 required)
- have measurable disease by protein electrophoresis analyses as defined by the following:
- ECOG performance status of 0, 1, or 2
Key exclusion criteria (18 listed)
- Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days (4 weeks) of randomization]
- Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study
- Any of the following laboratory abnormalities :
- Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following:
- Patients who have are unable or unwilling to undergo antithrombotic therapy
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 |
|---|---|---|
| melphalan-prednisone-thalidomide | Drug | melphalan-prednisone-thalidomide |
| lenalidomide-dexamethasone | Drug | lenalidomide-dexamethasone |
Primary outcome
best response to treatment
Time frame: 1 year
best response rate
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 1 Apr 2021.
- Results publication: PubMed 28835615Miannay B, Minvielle S, Roux O, Drouin P, Avet-Loiseau H, Guerin-Charbonnel C, Gouraud W, Attal M, Facon T, Munshi NC, Moreau P, Campion L, Magrangeas F, Guziolowski C. Logic programming reveals alteration of key transcription factors in multiple myeloma. Sci Rep. 2017 Aug 23;7(1):9257. doi: 10.1038/s41598-017-09378-9.
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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.
Philippe MOREAU, Pr study chair
Departement of clinical Hematology (University Hospital of Nantes)
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melphalan-prednisone-thalidomide and lenalidomide-dexamethasone in people with Myeloma, run by Intergroupe Francophone du Myelome at 26 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 18 inclusion and 18 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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.
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?
best response to treatment (time frame: 1 year). 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 NCT00907452, 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 1 Apr 2021.