Myeloma Multiple
Conditions
Keywords
myeloma multiple, newly diagnosed
Brief summary
Collection of retrospective additional data (survival, biological, disease response data) following the study IFM 2013-04.
Interventions
None listed
Sponsors
Nantes University Hospital
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient 1. \- 18 ≤ age \< 66 years 2. \- Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2 3. \- Patients must be eligible for Autologous Stem Cell Transplantation 4. \- Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day 5. \- Female patients of child-bearing potential (FCBP): * Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence. * Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy. 6. \- Male Patients: * Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy * Must agree to not donate semen during study drug therapy and for one week after discontinuation of study therapy 7. \- All patients must: * Agree to abstain from donating blood while taking study drug therapy and for one week after discontinuation of study drug therapy * Agree not to share study medication with another person. 8. \- Patients must be capable of giving informed consent 9. \- Patients must be affiliated with French social security system
Exclusion criteria
1. \- Asymptomatic Multiple myeloma 2. \- Non-secretory Multiple myeloma 3. \- Proven AL-amyloidosis 4. \- Age ≥ 66 years old 5. \- Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg) 6. \- Radiation therapy in the 2 weeks preceding randomization 7. \- National Cancer Institute grade ≥ 2 peripheral neuropathy 8. \- Haemoglobin \< 8g/dL 9. \- Absolute neutrophil count \< 1,000 cells / µL, platelet count \< 50,000 cells / µL 10. \- Creatinine level \> 170 µmol/L or requiring dialysis. 11. \- Bilirubin, transaminases or GamaGT \> 3 UNL (upper normal limit) 12. \- Positive HIV serology, evidence of active Hepatitis B and C infection 13. \- Severe active infection 14. \- Inability to comply with an anti-thrombotic treatment regimen 15. \- A personal medical history of severe psychiatric disease 16. \- Uncontrolled diabetes contraindicating the use of high-dose dexamethasone 17. \- Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) 18. \- A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation \> or = 5 years (except for basocellular skin cancer or in situ cervical cancer) 19. \- Use of any investigational drug in the 30 days preceding randomization 22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of death | 6 months | To evaluate Overall and Progression-Free Survival |
Countries
France
Outcome results
None listed