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

Investigating Long-term Safety of Investigational Medication for Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow

Recruiting
18 years or above
All
Phase 2
70 participants needed
1 Location

Study Overview

  • 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.

Study 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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Plasma Cell Myeloma
  • Age: 18 years or above
  • Gender: All

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.

Updated on 15 Feb 2024. Study ID: NCT05669989

This study investigates the long-term safety of an investigational medication in patients with multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The purpose of this study is to provide continued access to the investigational medication for patients who have completed a previous study with this treatment and are still benefiting from it.

Participants in this study will continue to receive the investigational medication either alone or in combination with other treatments. The study will monitor participants for any adverse effects and assess the safety of the ongoing treatment. Participants will remain in the study until they experience disease progression, unacceptable side effects, or choose to stop treatment.

  • Who can participate: Adults aged 18 and older who have completed a previous study involving the investigational medication and are still benefiting from it are eligible. Participants must not have progressive disease and must meet certain health criteria.
  • Study details: Participants will receive the investigational medication and will be monitored for safety. A placebo is not used in this study.
  • Study Timelines: The study will last 42 months.

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