Multiple Myeloma
Conditions
Keywords
Multiple myeloma, Newly Diagnosed
Brief summary
This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma. Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.
Detailed description
The patient population will consist of adult men and women who have a confirmed diagnosis of Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the patients consulting in an investigating centre's haematology service for newly diagnosed, symptomatic, untreated multiple myeloma. in each treatment arm there will be : 1. Induction therapy : 4 cycles of VTD (21 days)or VCD 2. Systematic stem cell harvest after cycle 3
Interventions
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 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 |
|---|---|---|
| Response assessment according to the criteria IMWG | 15-17 month | compare the Response assessment in both arms: the Very good partial remission rate (according to the criteria IMWG) achieved with four courses of VTD with that achieved with four courses of VCD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response assessment according to the criteria IMWG | 15 - 17 month | compare the Response assessment in both arms: the following parameters after induction treatment with four courses of VTD or four courses of VCD the Complete remission rate (according to the criteria IMWG) |
| Number of Adverse Events | 15-17 month | To evaluate the Safety of induction therapy |
| Number of death | 17 month | To evaluate Overall and Progression-Free Survival |
| Number of relapse according to the criteria IMWG | 17 month | Progression-Free Survival |
| Number of collected stem cell | 17 month | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of three techniques for the quantification of urinary monoclonal components in patients with Newly Diagnosed Multiple Myeloma. | 17 month | The detection and the estimation of the urinary monoclonal components is an inescapable element of the diagnosis and the evaluation of the therapeutic efficacy in the myeloma. Urinary protein, electrophoresisin agarose gel is the quantitative method of choice. In these labs, the quantification of the urinary monoclonal peak is not performed. In the absence of quantitative data on urinary monoclonal components, the patient is considered as non-assessable. Recently, the company Sebia has developed the quantification on two other materials used specifically for the characterization of monoclonal component and / or proteinuria (HYDRAGEL BENCE JONES and HYDRAGEL URINE PROFILE). The objective of this study is to compare the quantification of monoclonal components between the reference HR electrophoresis technique and the other two above-mentioned techniques. |
Countries
France
Outcome results
None listed