We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma

This study is currently recruiting participants.
Verified November 2017 by Sanofi
Sponsor:
ClinicalTrials.gov Identifier:
NCT02514668
First Posted: August 4, 2015
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

Primary Objective:

  • Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM).
  • Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab.

Secondary Objectives:

  • Part A:
  • To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM.
  • Part B:
  • To evaluate the safety of SAR650984 (isatuximab).
  • To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS).
  • To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline.
  • To evaluate the immunogenicity of SAR650984 (isatuximab).

Condition Intervention Phase
Plasma Cell Myeloma Drug: Isatuximab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Dose-escalation and Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SAR650984 (Isatuximab) in Patients With Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Part A: Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 4 weeks ]
  • Part A: Number of patients with adverse events (AEs) and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling [ Time Frame: Up to 30 days following the last administration of study treatment or up to 12 months for ongoing related AE, ongoing serious AE and new related AE ]
  • Part B: Overall Response Rate (ORR) [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Assessment of PK parameters: partial area under the serum concentration time curve (AUC) [ Time Frame: 1 week after first treatment ]
  • Assessment of PK parameters: maximum observed concentration (Cmax) [ Time Frame: 1 week after first treatment ]
  • Part B: Number of patients with AEs and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling [ Time Frame: Up to 30 days following the last administration of study treatment or up to 12 months for ongoing related AE, ongoing serious AE and new related AE ]
  • Part B: Duration of Response (DOR) [ Time Frame: Up to 12 months from the last patient in ]
  • Part B: Clinical Benefit Rate (CBR) [ Time Frame: Up to 12 months from the last patient in ]
  • Part B: Progression Free Survival (PFS) [ Time Frame: Up to 12 months from the last patient in ]
  • Part B: Levels of isatuximab antibodies [ Time Frame: Up to 12 months from the last patient in ]

Estimated Enrollment: 64
Study Start Date: September 1, 2015
Estimated Study Completion Date: June 24, 2019
Estimated Primary Completion Date: June 24, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isatuximab
Isatuximab (escalating dose) on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression
Drug: Isatuximab

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Other Name: SAR650984

Detailed Description:

Study duration for an individual patient will include a screening period for inclusion of up to 3 weeks, the treatment period and, a follow up period. Treatment with SAR650984 (isatuximab) may continue until disease progression, unacceptable adverse event, or other reason for discontinuation.

After study treatment discontinuation, an end of treatment visit will be done at 30 days to assess safety and PK, and at 30 and 60 days for anti-drug antibody (ADA). If the ADA is positive at Day 60, ADA will be repeated every 30 days until ADA is negative.

Patients with partial remission or better who discontinue treatment for reasons other than progression of disease will be followed monthly until progression or initiation of subsequent therapy, the final analysis cutoff date, whichever comes first.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Part A

  • Patients must have a known diagnosis of multiple myeloma (MM) with evidence of measurable disease, as defined below, and have evidence of disease progression based on International Myeloma Working Group (IMWG) criteria:
  • Serum M-protein ≥1g/dL, or urine M-protein ≥200 mg/24 hours, OR
  • In the absence of measurable M-protein, serum immunoglobulin free light chain ≥10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio.
  • Patients must have received at least 3 prior lines of therapy for MM and must include treatment with an immunomodulatory drug (IMiD) (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (for ≥2 cycles or ≥2 months of treatment). Induction therapy and stem cell transplant (± maintenance) will be considered as one regimen within a line, OR
  • Patients whose disease is double refractory to an IMiD and a proteasome inhibitor. For patients who have received more than one type of IMiD and proteasome inhibitor, their disease must be refractory to the most recent one.
  • Patients must have achieved a minimal response (MR) or better to at least one prior line of therapy.
  • Patients must have received an alkylating agent (for ≥2 cycles or ≥2 months of treatment) either alone or in combination with other MM treatments (history of stem cell transplant is acceptable). Treatment with high-dose Melphalan for stem cell transplantation meets this requirement.
  • Signed written informed consent and be willing and able to complete all study-related procedures.

Part B

  • Patients must have a known diagnosis of multiple myeloma (MM) with evidence of measurable disease, as defined below, and have evidence of disease progression based on International Myeloma Working Group (IMWG) criteria:
  • Serum M-protein ≥1g/dL, or urine M-protein ≥200 mg/24 hours, OR
  • In the absence of measurable M-protein, serum immunoglobulin free light chain ≥10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio.
  • Patients must have received at least 3 cycles of daratumumab treatment with at least 6 weeks from the last treatment with daratumumab to the first study treatment OR at least 2 cycles of daratumumab treatment in case another therapy is given between daratumumab and isatuximab with at least 12 weeks from the last treatment with daratumumab to the first study treatment.
  • Patients must have achieved MR or better to at least 1 prior line of therapy.
  • Signed written informed consent and be willing and able to complete all study-related procedures.

Exclusion criteria:

  • Patients <18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status >2.
  • Poor bone marrow reserve.
  • Poor organ function.
  • Known intolerance/hypersensitivity to IMiDs, dexamethasone, boron or mannitol, sucrose, histidine, or polysorbate 80.
  • Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or comorbid condition, which, in the opinion of the Investigator, could interfere with the safety, the compliance with the study, or with the interpretation of the results.
  • Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514668


Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
United States, Arizona
Investigational Site Number 840003 Recruiting
Scottsdale, Arizona, United States, 85054
United States, California
Investigational Site Number 840004 Recruiting
San Francisco, California, United States, 94117
United States, Michigan
Investigational Site Number 840011 Recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
Investigational Site Number 840015 Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Investigational Site Number 840005 Recruiting
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Investigational Site Number 840010 Recruiting
Durham, North Carolina, United States, 27707
United States, Ohio
Investigational Site Number 840013 Recruiting
Canton, Ohio, United States, 44718
United States, Tennessee
Investigational Site Number 840001 Recruiting
Nashville, Tennessee, United States, 37232
United States, Utah
Investigational Site Number 840002 Recruiting
Salt Lake City, Utah, United States, 84112-5550
United States, Wisconsin
Investigational Site Number 840006 Recruiting
Milwaukee, Wisconsin, United States, 53226
Czechia
Investigational Site Number 203001 Recruiting
Praha 2, Czechia, 12808
Estonia
Investigational Site Number 233001 Recruiting
Tallinn, Estonia, 13419
France
Investigational Site Number 250008 Recruiting
Creteil Cedex, France, 94010
Investigational Site Number 250005 Recruiting
Montpellier, France, 34295
Investigational Site Number 250002 Recruiting
Nantes Cedex 01, France, 44093
Investigational Site Number 250007 Recruiting
Paris, France, 75010
Investigational Site Number 250004 Recruiting
Pessac Cedex, France, 33604
Investigational Site Number 250003 Recruiting
Pierre Benite, France, 69310
Investigational Site Number 250001 Recruiting
Poitiers, France, 86021
Investigational Site Number 250006 Recruiting
Vandoeuvre-Les-Nancy, France, 54511
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02514668     History of Changes
Other Study ID Numbers: TED14154
U1111-1163-1073 ( Other Identifier: UTN )
First Submitted: July 31, 2015
First Posted: August 4, 2015
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases