Status:
WITHDRAWN
Elotuzumab in Patients With Multiple Myeloma Before and After Peripheral Stem Cell Autologous Graft
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Multiple Myeloma
Eligibility:
All Genders
66+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, open-label phase II study, assessing the efficacy of elotuzumab in elderly patients with multiple myeloma undergoing peripheral stem cell autologous graft
Detailed Description
In patients of 65 years of age or older, intensive treatment (TI) with hematopoietic stem cell autologous graft (ASCH) is not considered as the gold standard. Nowadays, given the rise of new treatment...
Eligibility Criteria
Inclusion
- Multiple myeloma de novo.
- Stage DS (Durie-Salmon) : III, II, I with at least 1 symptomatic bone lesion (confirmed by radiology).
- Age \> 65 years
- Indication for a first line treatment with induction, stem cell autologous graft and consolidation
- Available documentation including cytogenetic and International Staging System (ISS) of the initial diagnosis before inclusion,
- Effective contraceptive method for men with a partner of childbearing age during all the treatment period and within 6 months after the last cure
- Affiliated to social security
- Written informed consent
- Willingness and ability to respect the visits and all the demands required by the study
- Patient eligible to a high dose chemotherapy and fulfilling the following biological criteria :
- Neutrophils ≥ 1,0 × 109/L
- Platelets ≥ 75 ×109/L (platelets transfusions are not allowed within 3 days before inclusion)
- Total bilirubin ≤ 1,5 × upper limit.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit
- Creatinin clearance \> 50 mL/min
Exclusion
- Diagnosis and treatment for any other cancer within five years before inclusion or any diagnosis for any cancer. Patients with a skin cancer (except melanoma or carcinoma in situ) are not excluded in case of complete resection.
- Central nervous system disease
- Infection requiring an intravenous (IV) antibiotherapy or any severe infection within 14 days before inclusion
- Diagnosis of any of the following diseases : Waldenström disease, POEMS (polyneuropathy, endocrinopathy, organomegaly, monoclonal gammapathy and skin lesions), plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome or myeloproliferative disorder.
- Uncontrolled cardiopathy including : uncontrolled hypertension, uncontrolled heart arrhythmia, nonsymptomatic congestive cardiac failure, unstable angina or myocardial infarction within 6 months before inclusion
- Active infection with hepatitis B or C virus ; positive HIV serology
- Any comorbidity or severe concomitant disease incompatible with the patient inclusion or interfering with the safety assessment of the study treatments.
- Psychiatric history or any social condition limiting the patient compliance.
- Documented allergy to any studied treatment or any of their components.
- Disability to take oral treatments, inability or refusal to adhere to treatment constraints, or any digestive surgery interfering with oral absorption or treatment tolerance.
- Any experimental treatment within 30 days prior to the administration of the first dose of the studied treatmentParticipation to another clinical trial
- Prior participation to a clinical trial with elotuzumab, no matter the arm of treatment.
- Administration of any pharmaceutical speciality acting against myeloma - such as systemic corticosteroids (\>10 mg of prednisone equivalent a day) or clarithromycin - within the month prior to the inclusion. In case of emergency, patients can receive dexamethasone (40mg/day, 4 consecutive days, maximum dose of 160mg) between screening and randomization
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03393273
Start Date
February 20 2018
End Date
January 15 2019
Last Update
July 17 2019
Active Locations (1)
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1
Hématologie et thérapie cellulaire, Hôpital Saint Antoine
Paris, France, 75012