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RecruitingLast updated: 23 September 2025

LTS17704: This study will assess the long-term safety of targeted immunotherapy (called isatuximab) in adults with Multiple Myeloma who have previously participated in a isatuximab clinical trial.International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Trial purpose

Medical clipboardLong-term follow-up

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

LTS17704

Clinical summary

Summary

This multi-site treatment-extension study will provide participants with continued access to a form of targeted immunotherapy called isatuximab. 

The aim of the study is to assess long-term safety of isatuximab.

This study is available to adults with Multiple Myeloma who are still benefitting from isatuximab following completion of a Phase 1, 2, or 3 parental study.

Participants will receive isatuximab in isolation or in combination with other treatments, according to the treatment the patient received in the parential study. Treatment will be administered by IV infusion, subcutaneous injections and/or oral form (tablets/capsules).

Participants can continue the treatment until:

  • their disease progresses
  • they experience unacceptable side effects
  • they wish to discontinue the study treatment
  • the study treatment is commercially available and reimbursed in participant's country
  • or for any other reason

The overall study duration will be of approximately 42 months.

Conditions

This trial is treating people with Multiple Myeloma who have previously participated in a isatuximab clinical trial

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have previously participated in a certain specific clinical trial.
  • You are currently receiving treatment for your cancer.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT05669989 *
  • LTS17704; U1111-1277-6635; 2023-507180-19-00; 2022-002253-26

Trial sponsor

Sanofi

Scientific Title

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

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