NCT03089411UnknownNot Applicable
Collection of Additional Data Followed the Study "A Phase III Study of Velcade (Bortezomib) Thalidomide Dexaméthasone (VTD) Versus Velcade (Bortezomib) Cyclophosphamide Dexaméthasone (VCD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma"
Nantes University Hospital62 sites in 1 country340 target enrollmentStarted: March 20, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Nantes University Hospital
- Enrollment
- 340
- Locations
- 62
- Primary Endpoint
- Number of death
Study Overview
Brief Summary
Collection of retrospective additional data (survival, biological, disease response data) following the study IFM 2013-04.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 66 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Asymptomatic Multiple myeloma
- •Non-secretory Multiple myeloma
- •Proven AL-amyloidosis
- •Age ≥ 66 years old
- •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)
- •Radiation therapy in the 2 weeks preceding randomization
- •National Cancer Institute grade ≥ 2 peripheral neuropathy
- •Haemoglobin < 8g/dL
- •Absolute neutrophil count < 1,000 cells / µL, platelet count < 50,000 cells / µL
- •Creatinine level > 170 µmol/L or requiring dialysis.
- •Bilirubin, transaminases or GamaGT > 3 UNL (upper normal limit)
- •Positive HIV serology, evidence of active Hepatitis B and C infection
- •Severe active infection
- •Inability to comply with an anti-thrombotic treatment regimen
- •A personal medical history of severe psychiatric disease
- •Uncontrolled diabetes contraindicating the use of high-dose dexamethasone
- •Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)
- •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)
- •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
Outcomes
Primary Outcomes
Number of death
Time Frame: 6 months
To evaluate Overall and Progression-Free Survival
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (62)
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