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Closed (no longer recruiting)Last updated: 14 November 2023

This trial aims to evaluate the safety and effectiveness of a targeted cancer therapy in combination with a type of chemotherapy in multiple myeloma patients that have got worse or not responded to at least one prior treatmentA Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Clinical summary

Summary

Evaluation will occur in four parts, with Part 1 being used to determine the appropriate doses of venetoclax and carfilzomib to use in later parts of the trial. Until appropriate doses have been confirmed, eligible participants will receive Venetoclax at a dose of 400 mg or 800 mg; Carfilzomib at a dose of 20/27 mg/m2, 20/70 mg/m2, and/or 20/56 mg/m2; and Dexamethasone at a 40 mg dose. Parts 2-4 will further evaluate the safety and efficacy of the treatment combination.

Conditions

This trial is treating patients with multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

AbbVie

Scientific Title

A Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Eligibility

Inclusion

  • Eastern Collaborative Oncology Group (ECOG) performance score of less than or equal to 2.
  • Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy.
  • Positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
  • Received prior treatment with at least 1 prior line of therapy for MM.
  • Measurable disease on Screening per International Myeloma Working Group (IMWG) criteria.
  • Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug.

Exclusion

  • Has a pre-existing condition that is contraindicated including.

    • Non-secretory or oligo-secretory MM
    • Active plasma cell leukemia.
    • Waldenström's macroglobulinemia.
    • Primary amyloidosis.
    • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
    • Active hepatitis B or C infection based on screening blood testing.
    • Known active Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
    • Significant cardiovascular disease.
    • Major surgery within 4 weeks prior to first dose.
    • Acute infections requiring antibiotic, antifungal or antiviral therapy within14 days prior to first dose.
    • Peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to first dose.
    • Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to first dose.
    • Any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study.
  • History of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry Other protocol defined inclusion/exclusion criteria could apply

Inclusion

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

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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