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

NCT03393273 | Withdrawn Phase 2 DMC

• 2 other identifiers: P1701032017-001446-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Myeloma

Keywords

Stem Cell autologous graft; Elotuzumab; Multiple myeloma; Elderly

Outcome Measures

Primary Outcomes (1)

• Maximal response rate Assesment of the International Myeloma Working Group uniform response criteria

  Assesment of the International Myeloma Working Group uniform response criteria

  1 month after the last consolidation cure

Secondary Outcomes (6)

• survival and progression-free survival

  one year after the last consolidation cure

• evaluation of the answer to the treatment to improve or maintain the response

  12 month of treatment from inclusion

• Role of the consolidation phase in the improvement or maintenance of the response to the treatment Time before progression

  From inclusion to month 36

• Conversion from negative residual disease to positive residual disease or maintenance of a negative residual disease during all therapeutical phases

  from inclusion to month 36

• correlation between residual disease and duration of the response to the treatment

  From inclusion to the end of the 12 treatment-month

Study Arms (1)

Elotuzumab

EXPERIMENTAL

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.

Drug: Elotuzumab

Interventions

Elotuzumab DRUG

* Induction 4 cycles of 28 days Elotuzumab IV, 10 mg/Kg, D1, 8, 15, 22 Dexamethasone PO, 40 mg/d, D1, 8, 15 Velcade® IV, 1,3 mg/m2/d, D1, 4, 8, 11 Thalidomide PO, 100 mg/d, D1 to 21 * melphalan 140-200 mg/m2 one day followed by autologous hematopoietic stem cell transplantation * Consolidation 2 cycles of 28 days (2 to 3 months after autograft) Elotuzumab IV, 10 mg/Kg, D1, 8, 15 and 22 Dexamethasone PO, 40 mg/d, D1, 8 and 15 Velcade® IV, 1,3 mg/m2/d, D1, 4, 8, and 11 Thalidomide® PO, 100 mg/d, D1 to 21

Also known as: Empliciti®

Elotuzumab

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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
• Total bilirubin ≤ 1,5 × upper limit.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit
• Creatinin clearance \> 50 mL/min

You may not qualify if:

• Central nervous system disease
• 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.
• Active infection with hepatitis B or C virus ; positive HIV serology
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hématologie et thérapie cellulaire, Hôpital Saint Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

elotuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mohamad Mohty, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: January 8, 2018
• Study Start: February 20, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

FR (1)