Clinical Trial 24175

• Overview

  Study Title:

  Expanded Access Program for Mezigdomide (in combination with Carfilzomib/dex or Bortezomib/dex) For Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

  Summary:

  This is an expanded access designed to provide access to Mezigdomide for eligible participants.

  Objective:

  This program meets the following established FDA Expanded Access Criteria: Patient has a serious or immediately life-threatening disease or condition. There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. Patient enrollment in a clinical trial is not possible. Potential patient benefit justifies the potential risks of treatment. Providing the investigational medical product will not interfere with investigational trials that could support a medical product s development or marketing approval for the treatment indication.

• Inclusion Criteria

  Key Inclusion Criteria:
  • Males and females ≥ 18 years of age
  • Has been diagnosed with relapsed or refractory multiple myeloma
  • Has received lenalidomide and an anti-CD38 monoclonal antibody
  • As assessed by the healthcare provider (HCP), the patient is unable to tolerate available therapies, or no satisfactory or comparable approved treatment alternative options are available in the country
  • Evidence of disease progression on or after the last line of therapy
  • As confirmed by the prescribing physician, a suitable clinical study is not available, or the patient is not able to enroll for any reason (e.g. patient not eligible)
  • All patients must agree to the pregnancy prevention program requirements as detailed in the attached PPP document

• Exclusion Criteria

  Key Exclusion Criteria:
  • Prior treatment with mezigdomide
  • Has plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant light- chain amyloidosis
  • Has known active central nervous system involvement or exhibit clinical signs of meningeal involvement of multiple myeloma
  • Has contraindications or life-threatening allergies, hypersensitivity, or intolerance to mezigdomide or its excipients as listed in the Investigator's Brochure
  • Is pregnant or breastfeeding or planning to become pregnant during their participation in this program
  • Has significant lab abnormalities that would stop them from receiving the treatment
  • Has active infection requiring treatment with antibiotics, antiviral, or antifungal drugs, e.g. HIV positivity with virus load, hepatitis B, hepatitis A, hepatitis C
  • Administration of strong CYP3A modulators within 2 weeks of starting treatment; administration of proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) within 1 week of starting treatment
  • Current participation in another interventional treatment trial with an investigational agent, recent use of an investigational medicinal product within 28 days of the first dose of mezigdomide or presence of an investigational device at the time of screening
  • Is unable or unwilling to undergo required prophylactic treatments unless considered contraindicated by HCP

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