Elotuzumab in Patients With Multiple Myeloma Before and After Peripheral Stem Cell Autologous Graft

• Status: Withdrawn
• Trial end date: 2019-01-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Elotuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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