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Closed (no longer recruiting)Last updated: 4 April 2024

Metorite: This study is evaluating how safe and effective chemotherapy (azacitidine) in combination with best supportive care, compared to placebo and best supportive care, is in people with low to intermediate IPSS-R myelodysplastic syndromeA Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

Clinical summary

Summary

This study has two parts. The first part is seeking to determine the optimal dose of azacitidine. Eligible participants will be randomly allocated to receive oral azacitidine at one of two dose levels. The second part of this study is evaluating the effectiveness of azacitidine in addition to best supportive care, compared to placebo and best supportive care. Participants will be randomly allocated to receive either oral azacitidine plus best supportive care, or an oral placebo plus best supportive care.

Conditions

This trial is treating patients with low- to intermediate-risk International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II/III

Trial Acronym

Metorite

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

Eligibility

Inclusion

• Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5).

MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results.

• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion

  • Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy)
  • Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10%
  • Participants diagnosed with MDS with excess blasts-2 (MDS-EB2)
  • Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent

Other protocol-defined inclusion/exclusion criteria apply

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

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

Clinical trials have complex eligibility criteria.

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