International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Official title

International, Multi-center, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Are Still Benefitting From Isatuximab-based Therapy Following Completion of a Phase 1, 2, or 3 Parental Study

Overview

* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Detailed description

Participants can continue the treatment until disease progression, unacceptable adverse events, participant wish to discontinue study treatment, study treatment is commercially available and reimbursed in participant's country, or for any other reason, whichever comes first. The overall study duration will be of approximately 42 months.

Interventions

• Drug Isatuximab intravenous (IV)
  Route of administration: IV infusion; Pharmaceutical form: Vial
• Drug Cemiplimab (SAR439684)
  Route of administration: IV infusion; Pharmaceutical form: Vial
• Drug Dexamethasone
  Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial
• Drug Lenalidomide
  Route of administration: Oral; Pharmaceutical form: Capsules
• Drug Pomalidomide
  Route of administration: Oral; Pharmaceutical form: Hard capsules
• Drug Isatuximab subcutaneous (SC)
  Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial
• Drug Carfilzomib
  Route of administration: IV infusion; Pharmaceutical form: Vial

Primary outcome measures

• Number of participants with treatment-emergent adverse events [Time frame: Baseline to 42 months]

Eligibility criteria

Inclusion criteria

• Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent.
• Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed.
• Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A participant not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included.
• Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants.
• Capable of giving signed informed consent.

Exclusion criteria

• Participant has evidence of progressive disease during or at the time of the parental study closure.
• Participant has not recovered to ≤Grade 2 from nonhematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study.
• As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study.
• Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
• Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
• Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.
• Any country-related specific regulation that would prevent the participant from entering the study.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 7 centers

• Investigational Site Number : 7240006 — Seville
• Investigational Site Number : 7240004 — Santander
• Investigational Site Number : 7240005 — Badalona
• Investigational Site Number : 7241001 — Madrid
• Investigational Site Number : 7240001 — Pamplona
• Investigational Site Number : 7240003 — Madrid
• Investigational Site Number : 7240002 — Salamanca

Australia · 6 centers

• Investigational Site Number : 0360006 — Blacktown
• Investigational Site Number : 0360001 — Saint Leonards
• Investigational Site Number : 0360003 — Wollongong
• Investigational Site Number : 0360004 — Melbourne
• Investigational Site Number : 0360005 — Melbourne
• Investigational Site Number : 0360002 — Richmond

Brazil · 3 centers

• Hospital Mae de Deus- Site Number : 0760003 — Porto Alegre
• Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Sit — São Paulo
• Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Si — Rio de Janeiro

Czechia · 3 centers

• Investigational Site Number : 2030002 — Brno
• Investigational Site Number : 2030003 — Ostrava
• Investigational Site Number : 2030001 — Prague

Greece · 3 centers

• Investigational Site Number : 3000004 — Athens
• Investigational Site Number : 3000003 — Athens
• Investigational Site Number : 3000001 — Pátrai

New Zealand · 2 centers

• Investigational Site Number : 5540002 — Auckland
• Investigational Site Number : 5540001 — Wellington

Russia · 2 centers

• Investigational Site Number : 6430002 — Kirov
• Investigational Site Number : 6430001 — Moscow

South Korea · 2 centers

• Investigational Site Number : 4100001 — Seoul
• Investigational Site Number : 4100002 — Seoul

United States · 1 center

• Washington University- Site Number : 8400001 — St Louis

Chile · 1 center

• Investigational Site Number : 1520001 — Temuco

China · 1 center

• Investigational Site Number : 1560001 — Tianjin

Finland · 1 center

• Investigational Site Number : 2460001 — Helsinki

France · 1 center

• Investigational Site Number : 2500002 — Nantes

Italy · 1 center

• Investigational Site Number : 3800002 — Torino

Japan · 1 center

• Investigational Site Number : 3920001 — Okayama

Sweden · 1 center

• Investigational Site Number : 7520004 — Luleå

Taiwan · 1 center

• Investigational Site Number : 1580001 — Taichung

Identifiers

NCT: NCT05669989 · LTS17704 · U1111-1277-6635 · 2023-507180-19 · 2022-002253-26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗