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Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies

NCT01084252 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2024-11-01

Study results available
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Summary

Primary Objective:

Phase 1:

To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab).

Phase 2 (stage 1):

To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone.

Phase 2 (stage 2):

To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm).

Secondary Objectives:

Phase 1:

* To characterize the global safety profile including cumulative toxicities.
* To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s).
* To assess the pharmacodynamics (PD), immune response, and preliminary disease response.

Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent:

* Safety
* Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.

Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex):

* Safety
* Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.
* Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status.
* Pharmacokinetic profile of Isatuximab.
* Immunogenicity of Isatuximab.
* Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response.

Conditions

  • Hematological Malignancy

Interventions

DRUG

Isatuximab SAR650984

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

Dexamethasone

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

Dexamethasone

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-11
Primary Completion
2018-12-21
Completion
2023-07-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Chile
  • Finland
  • France
  • Greece
  • Israel
  • Italy
  • Mexico
  • Peru
  • Russia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084252 on ClinicalTrials.gov