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Clinical Trial VICCHEM12107

Title

A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide (POM), Bortezomib (BTZ) and Low-Dose Dexamethasone (LD-DEX) versus Bortezomib and Low-Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma (MM)

Principal Investigator(s)

Madan Jagasia

Details

  • Protocol No. VICCHEM12107
  • Open Date: 03/31/2013
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To compare the efficacy and safety of POM + BTZ + LD-DEX with BTZ + LD-DEX in subjects with relapsed or refractory MM
  • Disease Sites: Multiple Myeloma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Bortezomib (BTZ); Dexamethasone; Pomalidomide (POM)(CC-4047); VELCADE
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01734928
  • Secondary Protocol No: CC-4047-MM-007

Description

Patients are asked to take part in this research study because they have been diagnosed with multiple myeloma, a cancer of plasma cells (a type of immune cell that produces antibodies) in the bone marrow that has either returned after the patient's most recent treatment regimen (relapsed) or has not responded to their most recent treatment regimen (refractory). The purpose of this study is to see how well the combination of pomalidomide, bortezomib and dexamethasone works compared to the combination of bortezomib and dexamethasone. The study will also be assessing how safe the combination of pomalidomide, bortezomib and dexamethasone is and how this combination treatment affects the patient's quality of life compared to the combination of bortezomib and dexamethasone.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Must be ≥ 18yrs at the time of signing informed consent.
• Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
• Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
• Must have documented disease progression during or after their last anti-myeloma therapy.
• All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.
Exclusion Criteria:
• Refractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 dose twice weekly dosing schedule.
• Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
• Non-secretory multiple myeloma.
• Subjects with severe renal impairment requiring dialysis.
• Previous therapy with pomalidomide.