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

Study Purpose

  • - This is a multi-center, open-label, Phase 2 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.
  • - 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 patient 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05669989
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sanofi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Sciences & Operations
Principal Investigator Affiliation Sanofi
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Brazil, Chile, China, Czechia, Finland, France, Greece, Italy, Japan, Korea, Republic of, Russian Federation, Spain, Sweden, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plasma Cell Myeloma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Isatuximab

Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the patient received on the parental protocol

Interventions

Drug: - Isatuximab IV (SAR650984)

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 Pharmaceutical form: Tablets

Drug: - Lenalidomide

Route of administration: Oral Pharmaceutical form: Capsules

Drug: - Pomalidomide

Route of administration: Oral Pharmaceutical form: Hard capsules

Drug: - Isatuximab SC (SAR650984)

Route of administration: SC injection with the investigational isatuximab injector device Pharmaceutical form: Vial

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine Site Number : 8400001

Saint Louis, Missouri, 63110

International Sites

Investigational Site Number : 0360001, St Leonards, New South Wales, Australia

Status

Recruiting

Address

Investigational Site Number : 0360001

St Leonards, New South Wales, 2065

Investigational Site Number : 0360003, Wollongong, New South Wales, Australia

Status

Recruiting

Address

Investigational Site Number : 0360003

Wollongong, New South Wales, 2500

Investigational Site Number : 0360004, Fitzroy, Victoria, Australia

Status

Recruiting

Address

Investigational Site Number : 0360004

Fitzroy, Victoria, 3065

Investigational Site Number : 0360002, Richmond, Victoria, Australia

Status

Recruiting

Address

Investigational Site Number : 0360002

Richmond, Victoria, 3121

Rio De Janeiro, Brazil

Status

Recruiting

Address

Instituto COI de Educacao e Pesquisa Site Number : 0760001

Rio De Janeiro, , 22775-002

Investigational Site Number : 1520001, Temuco, Chile

Status

Recruiting

Address

Investigational Site Number : 1520001

Temuco, , 4800827

Investigational Site Number : 1560001, Tianjin, China

Status

Recruiting

Address

Investigational Site Number : 1560001

Tianjin, , 300020

Investigational Site Number : 2030001, Praha 2, Czechia

Status

Recruiting

Address

Investigational Site Number : 2030001

Praha 2, , 12808

Investigational Site Number : 2460001, Helsinki, Finland

Status

Recruiting

Address

Investigational Site Number : 2460001

Helsinki, , 00029

Investigational Site Number : 2500002, Nantes, France

Status

Recruiting

Address

Investigational Site Number : 2500002

Nantes, , 44093

Investigational Site Number : 3000001, Patra, Greece

Status

Recruiting

Address

Investigational Site Number : 3000001

Patra, , 26504

Investigational Site Number : 3800002, Torino, Italy

Status

Recruiting

Address

Investigational Site Number : 3800002

Torino, , 10126

Investigational Site Number : 3920001, Okayama-shi, Okayama, Japan

Status

Recruiting

Address

Investigational Site Number : 3920001

Okayama-shi, Okayama, 701-1192

Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of

Status

Recruiting

Address

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03080

Investigational Site Number : 6430001, Moscow, Russian Federation

Status

Recruiting

Address

Investigational Site Number : 6430001

Moscow, , 125284

Investigational Site Number : 7240004, Santander, Cantabria, Spain

Status

Recruiting

Address

Investigational Site Number : 7240004

Santander, Cantabria, 39008

Investigational Site Number : 7241001, Madrid, Madrid, Comunidad De, Spain

Status

Recruiting

Address

Investigational Site Number : 7241001

Madrid, Madrid, Comunidad De, 28027

Investigational Site Number : 7240001, Pamplona, Navarra, Spain

Status

Recruiting

Address

Investigational Site Number : 7240001

Pamplona, Navarra, 31008

Investigational Site Number : 7240003, Madrid, Spain

Status

Recruiting

Address

Investigational Site Number : 7240003

Madrid, , 28041

Investigational Site Number : 7240002, Salamanca, Spain

Status

Recruiting

Address

Investigational Site Number : 7240002

Salamanca, , 37007

Investigational Site Number : 7520004, Luleå, Sweden

Status

Recruiting

Address

Investigational Site Number : 7520004

Luleå, , 97180

Investigational Site Number : 1580001, Taichung, Taiwan

Status

Recruiting

Address

Investigational Site Number : 1580001

Taichung, , 40447