Clinical trial · Interventional
Elotuzumab in Patients With Multiple Myeloma Before and After Peripheral Stem Cell Autologous Graft
Induction and Consolidation With Elotuzumab Before and After Peripheral Stem Cell Autologous Graft in Elderly Patients With Multiple Myeloma
NCT03393273CI-TRIAL-00039524IFM2016-03withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator decision in accordance with the promotor
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elotuzumab | Drug | Elotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Elotuzumab
- description
- This is a single arm phase II trial to assess the Very Good Partial Response rate of a strategy involving autologous hematopoietic stem cell transplantation, after intensive treatment and followed by consolidation phase, with elotuzumab, dexamethasone, velcade, and thalidomide in elderly patients.
- interventionNames
- Drug: Elotuzumab
Primary outcomes (1)
- measure
- Maximal response rate Assesment of the International Myeloma Working Group uniform response criteria
- timeFrame
- 1 month after the last consolidation cure
- description
- Assesment of the International Myeloma Working Group uniform response criteria
Secondary outcomes (6)
- measure
- survival and progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 66 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.