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Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients (Islands)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812706
Recruitment Status : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objectives:

  • Phase I: To evaluate safety and tolerability of isatuximab in Japanese patients with relapsed and refractory multiple myeloma.
  • Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese patients with relapsed and refractory multiple myeloma.

Secondary Objectives:

  • To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events will be assessed.
  • To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule.
  • To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria.
  • To assess the relationship between baseline CD38 receptor density on multiple myeloma cells and efficacy.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Isatuximab SAR650984 Phase 1 Phase 2

Detailed Description:
The study duration for an individual patient will include a screening period for inclusion of up to 21 days, the treatment period consisting of 28 day cycles and a follow-up period. Treatment with isatuximab may continue until disease progression, unacceptable adverse event or other reason for discontinuation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Isatuximab (Anti-CD38 mAb) Administered as a Single Agent in Japanese Patients With Relapsed and Refractory Multiple Myeloma
Actual Study Start Date : September 5, 2016
Actual Primary Completion Date : July 31, 2018
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Isatuximab
Isatuximab will be administered intravenously (IV) once every week (QW) for 4 weeks followed by once every other week (Q2W)
Drug: Isatuximab SAR650984
Pharmaceutical form:solution Route of administration: intravenous
Other Name: Sarclisa




Primary Outcome Measures :
  1. Phase I: Dose Limiting Toxicities (DLT) [ Time Frame: 28 days ]
  2. Phase II: Overall Response Rate (ORR) [ Time Frame: 4 months after the date of the first dose of the last patient ]

Secondary Outcome Measures :
  1. Number of patients with Treatment-emergent adverse events/serious adverse events (TEAE/SAE) [ Time Frame: Up to approximately 30 days after the last study treatment ]
  2. Clinical Benefit Rate (CBR) [ Time Frame: 4 months after the date of the first dose of the last patient ]
  3. Overall Survival (OS) [ Time Frame: months after the date of the first dose of the last patient ]
  4. Progression Free Survival (PFS) [ Time Frame: 12 months after the date of the first dose of the last patient ]
  5. Duration of Response (DOR) [ Time Frame: 12 months after the date of the first dose of the last patient ]
  6. Time to Progression (TTP) [ Time Frame: 12 months after the date of the first dose of the last patient ]
  7. Assessment of PK parameter: Concentration observed at the end of an intravenous infusion (Ceoi) [ Time Frame: Up to approximately 30 days after the last study treatment ]
  8. Assessment of PK parameter: Maximum observed concentration (Cmax) [ Time Frame: Up to approximately 30 days after the last study treatment ]
  9. Assessment of PK parameter: Time to reach the maximum concentration (Tmax) [ Time Frame: Up to approximately 30 days after the last study treatment ]
  10. Assessment of PK parameter: Concentrations just before drug infusion (Ctrough) [ Time Frame: Up to approximately 30 days after the last study treatment ]
  11. Assessment of PK parameter: AUC over the dosing interval [ Time Frame: Up to approximately 30 days after the last study treatment ]
  12. CD38 receptor density levels [ Time Frame: Baseline ]
  13. Level of anti-drug antibodies (ADA) [ Time Frame: Up to approximately 60 days after the last study treatment ]


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.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Males or females, age 20 years or older.
  • Patient must have a known diagnosis of symptomatic multiple myeloma.
  • Patients must have received at least 3 prior lines of therapies OR Patients whose disease is double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI).
  • Subject must have been responsive (ie, minimal response [MR] or better) to at least one prior line of therapy.
  • Refractory to the most recently received IMiD or PI included therapy.
  • Patients with measurable disease defined as at least one of the following:
  • IgG Type: Serum M-protein ≥1 g/dL (≥10 g/L);
  • IgA and D Type: Serum M-protein, quantification should be performed;
  • Urine M-protein ≥200 mg/24 hours.
  • Patients with a Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

Exclusion criteria:

  • Patients treated with any anti-CD38 agent.
  • Diagnosed or treated for another malignancy within 5 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
  • Prior anticancer therapy (chemotherapy, targeted agents, immunotherapy) within 21 days prior to the first drug infusion unless otherwise specified below:
  • Alkylating agents (eg, Melphalan) within 28 days prior to the first dose of study treatment.
  • Steroids treatment (eg, prednisone >10 mg/day orally or equivalent except patients being treated for adrenal insufficiency/replacement therapy or treated for inhalation corticosteroids) within 14 days prior to the first dose of study treatment.
  • Participated in another clinical trial within 30 days prior to the first dose of study treatment.
  • Patients treated with systemic radiation therapy within 4 weeks prior to the first dose of study treatment OR Localized radiation therapy within 1 week prior to the first dose of study treatment.
  • Major surgical procedure within 4 weeks prior to the first dose of study treatment.
  • Any toxicity Grade ≥2 (excluding alopecia, neutropenia or neuropathy) related to any prior anti-cancer therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
  • Neuropathy Grade ≥3 or painful peripheral neuropathy Grade ≥2.
  • History of significant cardiovascular disease unless the disease within the past 6 months is well-controlled.
  • Previously received an allogenic stem cell transplant.
  • Diagnosed Crow-Fukase (POEMS) syndrome OR plasma cell leukemia.
  • Patients with known or suspected amyloidosis.
  • Patients with Waldenstrom's macroglobulinemia OR Multiple myeloma IgM subtype.
  • Patients with active infection.
  • Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection.
  • Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.
  • 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.
  • Hypersensitivity or history of intolerance to boron or mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to pre-medication with steroids and H2 blockers or would prohibit further treatment with these agents.

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


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): NCT02812706


Locations
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Japan
Investigational Site Number 392012
Chuo-Ku, Japan
Investigational Site Number 392010
Hiroshima-Shi, Japan
Investigational Site Number 392015
Kanazawa-Shi, Japan
Investigational Site Number 392016
Kyoto-Shi, Japan
Investigational Site Number 392001
Nagoya-Shi, Japan
Investigational Site Number 392003
Okayama-Shi, Japan
Investigational Site Number 392009
Osaka-Shi, Japan
Investigational Site Number 392005
Shibukawa-Shi, Japan
Investigational Site Number 392002
Shibuya-Ku, Japan
Investigational Site Number 392013
Suita-Shi, Japan
Investigational Site Number 392017
Sunto-Gun, Japan
Investigational Site Number 392008
Suwa-Shi, Japan
Investigational Site Number 392011
Yamagata-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02812706    
Other Study ID Numbers: TED14095
U1111-1175-0679 ( Other Identifier: UTN )
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
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 we continue to protect the privacy of the participants in our 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
Keywords provided by Sanofi:
Anti-CD38 monoclonal antibody
Additional relevant MeSH terms:
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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