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RecruitingLast updated: 8 January 2024

IRAKLIA: This phase III study is evaluating different methods of administered targeted therapy (isatuximab) when given in additional to combination therapy (pomalidomide and dexamethasone) in people with relapsed or refractory multiple myeloma who have had previous treatmentA Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive isatuximab administered via subcutaneous injection weekly for 4 weeks during Cycle 1 (Days 1, 8, 15 and 22) and Day 1 and 15 of subsequent cycles. In the Active Comparator Arm, participants will receive isatuximab administered via intravenous infusion weekly for 3 weeks during Cycle 1 (Days 1, 8, 15 and 22) and Day 1 and 15 of each subsequent cycle. Each cycle will be 28 days in duration. All participants will also receive pomalidomide, to be taken orally on Day 1 to Day 21 of each cycle at the time that is is most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day, as well as dexamethasone to betaken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).

Conditions

This trial is treating patients with relapsed or refractory multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

IRAKLIA

More information

Trial Identifiers

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Trial sponsor

Sanofi

Scientific Title

A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Eligibility

Inclusion

  • Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
  • Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65)).

Exclusion

  • Primary refractory multiple myeloma participants
  • Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
  • Prior therapy with pomalidomide
  • Participants with inadequate biological tests.
  • Significant cardiac dysfunction
  • Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
  • Concomitant plasma cell leukemia
  • Active primary amyloid light -chain amyloidosis
  • Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
  • Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
  • Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control

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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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