ClinicalTrials.gov record

Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT01084252

Public ClinicalTrials.gov record NCT01084252. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD38+ Hematological Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01084252
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Sanofi; Industry
Enrollment: 351 participants

Conditions and interventions

Conditions

Hematological Malignancy

Interventions

Isatuximab SAR650984 Drug
Dexamethasone Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 11, 2010 (Actual)
Primary completion: Dec 21, 2018 (Actual)
Completion: Jul 13, 2023 (Actual)
Last update posted: Nov 1, 2024

2010 – 2023

United States locations

U.S. sites: 16
U.S. states: 15
U.S. cities: 16

Facility	City	State	ZIP	Site status
Mayo Clinic Site Number : 840003	Scottsdale	Arizona	85054	—
UCSF MS Center Site Number : 840005	San Francisco	California	94117	—
Emory University Site Number : 840009	Atlanta	Georgia	30322	—
University of Chicago Site Number : 840010	Chicago	Illinois	60637	—
The University Of Michigan Site Number : 840022	Ann Arbor	Michigan	48109-0759	—
Karmanos Cancer Center Site Number : 840027	Detroit	Michigan	48201	—
Mayo Clinic of Rochester Site Number : 840018	Rochester	Minnesota	55905	—
Washington University School of Medicine Site Number : 840013	St Louis	Missouri	63110	—
The Cancer Center At Hackensack University Medical Site Number : 840011	Hackensack	New Jersey	07601	—
Memorial Sloan-Kettering Cancer Center Site Number : 840014	New York	New York	10021	—
Duke University Medical College Site Number : 840016	Durham	North Carolina	27707	—
University of Cincinnati Site Number : 840004	Cincinnati	Ohio	45267-0542	—
Vanderbilt University Site Number : 840001	Nashville	Tennessee	37232	—
Huntsman Cancer Institute at the University of Utah Site Number : 840002	Salt Lake City	Utah	84112-5550	—
Fred Hutchinson Cancer Research Center Site Number : 840012	Seattle	Washington	98109	—
Medical College of Wisconsin Site Number : 840017	Milwaukee	Wisconsin	53226	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01084252, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 1, 2024 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01084252 live on ClinicalTrials.gov.

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