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Myelodysplastic Syndrome

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Onconova INSPIRE

"A Phase III, International, Randomized, Controlled Study of Rigosertib vs. Physician's Choice of Treatment in Patients with Myelodysplastic Syndrome After Failure of a Hypomethylating Agent"

Study Objective: The study's primary objective (in a population of patients with MDS after failure of treatment with azacitidine [AZA] or decitabine [DAC] is to compare the overall survival [OS] of patients in the rigosertib group vs. the physician's choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

  • Experimental Arm: rigosertib + best supportive care
  • Active Comparator: Physician's choice + best supportive care


Key Inclusion Criteria:

  • 18 years to 81 years
  • MDS classified as follows:
    • RAEB-1 per World Health Organization (WHO) MDS criteria (5% to <10% BM blasts)
    • RAEB-2 per WHO MDS criteria (10% to <20% BM blasts)
    • RAEB-t per French-American-British (FAB) classification (20% to 30% BM blasts)

 

Principal Investigator: Jason Suh, M.D.

Click here for more information on Inspire
 


 

BOSTON

A Phase 3 Randomized, Controlled, Open-Label Study of Selinexor, Bortezomib, and Dexamethasone (SVD) Versus Bortezomib and Dexamethasone (VD) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
 
Treatment:
  • Arm 1: Selinexor + Bortezomib + Dexamethasone
  • Arm 2: Bortezomib + Dexamethasone
 
Inclusion:
  • Had at least 1 prior regimen and nor more than 3 prior regimens. 
  • Prior treatment with bortezomib or other proteasome inhibitor is allowed provided patient mets all of the criteria below
    • Best response achieved with prior bortezomib at any time was ≥PR and with the last proteasome inhibitor therapy (alone or in combination) was ≥PR, AND
    • Participant did not discontinue bortezomib due to ≥3 related toxicity, AND
    • Must have had at least 6 month proteasome inhibitor- treatment- free interval prior to C1D1 of study treatment
 
Exclusion:
  • Spinal cord compression
  • Documented systemic light chain amyloidosis
 
Principal Investigator: Jason Suh, MD

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