Isatuximab in combination with anti-TGFß in RRMM

Phase 1

• Conditions: Plasma cell myeloma refractory; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003024-16-IT
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

-Participants who have received at least 3 prior lines of therapy for Multiple myeloma or at least 2 prior lines if at least one of these lines consisted of 2 or more multiagent regimens. Prior exposure to drugs targeting CD38 is allowed with a wash-out of at least 6 months after the last dose.
-Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
-measurable disease.
-Capable of giving signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
-Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to randomization.
-Uncontrolled or active hepatitis B or C virus.
-Malabsorption syndrome.
-Any anti-MM drug treatment within 14 days before randomization, including dexamethasone.
-Inadequate organ functions.
-Corrected serum calcium >14 mg/dL (>3.5 mmol/L).
-Sensitivity to any of the study interventions.
-Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified