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

NCT ID: NCT05669989

Condition: Plasma Cell Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Lenalidomide
Pomalidomide
Cemiplimab
Antibodies, Monoclonal

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Isatuximab intravenous (IV)
Description: Route of administration: IV infusion; Pharmaceutical form: Vial
Arm group label: Isatuximab

Other name: SARCLISA®, SAR650984

Intervention type: Drug
Intervention name: Cemiplimab (SAR439684)
Description: Route of administration: IV infusion; Pharmaceutical form: Vial
Arm group label: Isatuximab

Intervention type: Drug
Intervention name: Dexamethasone
Description: Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial
Arm group label: Isatuximab

Intervention type: Drug
Intervention name: Lenalidomide
Description: Route of administration: Oral; Pharmaceutical form: Capsules
Arm group label: Isatuximab

Intervention type: Drug
Intervention name: Pomalidomide
Description: Route of administration: Oral; Pharmaceutical form: Hard capsules
Arm group label: Isatuximab

Intervention type: Drug
Intervention name: Isatuximab subcutaneous (SC)
Description: Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial
Arm group label: Isatuximab

Other name: SARCLISA®, SAR650984

Intervention type: Drug
Intervention name: Carfilzomib
Description: Route of administration: IV infusion; Pharmaceutical form: Vial
Arm group label: Isatuximab

Summary: - 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Washington University School of Medicine- Site Number : 8400001

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 0360006

Address:
City: Blacktown
Zip: 2148
Country: Australia

Status: Recruiting

Facility:
Name: Investigational Site Number : 0360001

Address:
City: St Leonards
Zip: 2065
Country: Australia

Status: Recruiting

Facility:
Name: Investigational Site Number : 0360003

Address:
City: Wollongong
Zip: 2500
Country: Australia

Status: Recruiting

Facility:
Name: Investigational Site Number : 0360004

Address:
City: Fitzroy
Zip: 3065
Country: Australia

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 0360005

Address:
City: Heidelberg West
Zip: 3081
Country: Australia

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 0360002

Address:
City: Richmond
Zip: 3121
Country: Australia

Status: Active, not recruiting

Facility:
Name: Instituto COI de Educacao e Pesquisa- Site Number : 0760001

Address:
City: Rio De Janeiro
Zip: 22775-002
Country: Brazil

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 1520001

Address:
City: Temuco
Zip: 4800827
Country: Chile

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 1560001

Address:
City: Tianjin
Zip: 300020
Country: China

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 2030002

Address:
City: Brno
Zip: 62500
Country: Czechia

Status: Recruiting

Facility:
Name: Investigational Site Number : 2030003

Address:
City: Ostrava - Poruba
Zip: 70852
Country: Czechia

Status: Recruiting

Facility:
Name: Investigational Site Number : 2030001

Address:
City: Praha 2
Zip: 12808
Country: Czechia

Status: Recruiting

Facility:
Name: Investigational Site Number : 2460001

Address:
City: Helsinki
Zip: 00029
Country: Finland

Status: Completed

Facility:
Name: Investigational Site Number : 2500002

Address:
City: Nantes
Zip: 44093
Country: France

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 3000004

Address:
City: Athens
Zip: 10676
Country: Greece

Status: Recruiting

Facility:
Name: Investigational Site Number : 3000003

Address:
City: Athens
Zip: 11528
Country: Greece

Status: Recruiting

Facility:
Name: Investigational Site Number : 3000001

Address:
City: Patra
Zip: 26504
Country: Greece

Status: Recruiting

Facility:
Name: Investigational Site Number : 3800002

Address:
City: Torino
Zip: 10126
Country: Italy

Status: Recruiting

Facility:
Name: Investigational Site Number : 3920001

Address:
City: Okayama-shi
Zip: 701-1192
Country: Japan

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 4100001

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Investigational Site Number : 4100002

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Investigational Site Number : 6430002

Address:
City: Kirov
Zip: 610027
Country: Russian Federation

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 6430001

Address:
City: Moscow
Zip: 125284
Country: Russian Federation

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 7240004

Address:
City: Santander
Zip: 39008
Country: Spain

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 7241001

Address:
City: Madrid
Zip: 28027
Country: Spain

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 7240001

Address:
City: Pamplona
Zip: 31008
Country: Spain

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 7240003

Address:
City: Madrid
Zip: 28041
Country: Spain

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 7240002

Address:
City: Salamanca
Zip: 37007
Country: Spain

Status: Active, not recruiting

Facility:
Name: Investigational Site Number : 7520004

Address:
City: Luleå
Zip: 97180
Country: Sweden

Status: Recruiting

Facility:
Name: Investigational Site Number : 1580001

Address:
City: Taichung
Zip: 40447
Country: Taiwan

Status: Completed

Start date: April 5, 2023

Completion date: November 30, 2026

Lead sponsor:
Agency: Sanofi
Agency class: Industry

Source: Sanofi

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05669989

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