Clinical Trials /

Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma

NCT04287855

Description:

study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma. Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Each cycle of treatment lasts 28 days. Cycle 1 to 13 : treatment phase After cycle 13 : maintenance phase

Related Conditions:
  • Multiple Myeloma
  • Non-Secretory Plasma Cell Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma
  • Official Title: Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: IsKPd - IFM2018-03
  • NCT ID: NCT04287855

Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma, Refractory

Interventions

DrugSynonymsArms
Isatuximab
Carfilzomib
Pomalidomide

Purpose

study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma. Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Each cycle of treatment lasts 28 days. Cycle 1 to 13 : treatment phase After cycle 13 : maintenance phase

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        Inclusion Criteria:

          -  Life expectancy of > 6 months.

          -  Must be in Relapse 1 (Line 2) and Relapse 2 (Line 3) Multiple Myeloma (MM) with a
             measurable disease

          -  Must have measurable disease as defined by the following: must have a clearly
             detectable and quantifiable monoclonal M-component value in the serum and/or urine.

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

          -  Wash out period without MM treatment must be of 28 days minimum before Cycle1 Day1,
             except for anti CD-38 (Cluster Differentiation 38)

          -  Adequate bone marrow function, documented within 72 hours and without transfusion 72
             hours prior to the first intake of investigational product (Cycle1 Day1) with no
             growth factor support (one week)

          -  Adequate organ function

          -  Patient affiliated to an appropriate social security system

          -  A man who is sexually active with a pregnant female or a FCBP*(Female of Child Bearing
             Potential) must agree to use a barrier method of birth control

          -  A woman FCBP* must understand and agree to use 2 reliable effective methods of
             contraception simultaneously without interruption

          -  All patients must agree to not donate blood during the treatment period, interruptions
             of treatment and at least 19 weeks after the last dose of treatment

          -  All patients must understand and accept to comply with the conditions of the
             Pomalidomide pregnancy prevention plan * FCBP : Female of Child Bearing Potential is
             any sexually mature female who:1) has achieved menarche at some point, 2) has not
             undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally
             postmenopausal (not having menstrual cycles due to cancer therapy does not rule out
             childbearing potential) for at least 24 consecutive months.

        Exclusion Criteria:

          -  Known positive for HIV or active infectious hepatitis, type B or C.

          -  Patients with non-secretory Multiple Myeloma (MM) and non-measurable MM

          -  Patient with terminal renal failure that require dialysis or clearance creatinine < 30
             ml/min

          -  Any uncontrolled or severe cardiovascular or pulmonary disease

          -  Prior history of malignancies, other than multiple myeloma, unless the patients has
             been free of the disease for ≥ 5 years.

          -  Evidence of central nervous system (CNS) involvement

          -  Ongoing active infection or other clinically significant uncontrolled cardiovascular
             events

          -  Unable to comply with Immunomodulatory drugs (IMids) regulation to thromboprophylaxis,
             or teratogenic recommendations.

          -  Patients can be exposed to anti CD38 (any), the wash out period for patient
             pre-treated with an anti CD38 antibody must be of 4,5 months minimum between last dose
             of previous anti-CD38 antibody and the first dose of isatuximab.

          -  Previously exposed to pomalidomide

          -  Any ongoing non hematological adverse event grade > 2 severity or medical history
             grade > 2 severity
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Efficacy of trial treatment
Time Frame:Up to 5 years
Safety Issue:
Description:Fraction of patients who experience a Minimal Residual Disease (MRD) 10-5 per IMWG (International Myeloma Working Group) criteria

Secondary Outcome Measures

Measure:Safety of trial treatment
Time Frame:Up to 5 years
Safety Issue:
Description:List of AE frequency (AE assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 5.0)
Measure:Depth of response to the trial treatment
Time Frame:Up to 5 years
Safety Issue:
Description:Per International Myeloma Working Group (IMWG) criteria
Measure:Progression Free survival
Time Frame:Up to 5 years
Safety Issue:
Description:Time to relapse or death, whichever occurs first

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Poitiers University Hospital

Last Updated

February 26, 2020