Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
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.
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
- Enrollment
- 351 participants
Conditions and interventions
Conditions
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 10, 2010
- Primary completion
- Dec 20, 2018
- Completion
- Jul 12, 2023
- Last update posted
- Oct 31, 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.
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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 Oct 31, 2024 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01084252 live on ClinicalTrials.gov.