A Study of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in Relapsed and/or Refractory… (NCT01297764) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
United States17 participantsStarted 2011-04
Plain-language summary
This study will evaluate the feasibility of combining four of the most active agents available for the treatment of multiple myeloma. Further the investigators will attempt to assess the activity of this combination.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Symptomatic multiple myeloma
✓. Relapsed and/or refractory multiple myeloma after at least one prior therapeutic regimen for multiple myeloma
✓. Prior treatment with immunomodulatory agents, proteasome inhibitors and histone deacetylase inhibitors is permitted. (Patients who have used HDAC inhibitors, including valproic acid , must have at least 5 half-lives wash out period before beginning therapy with vorinostat on this protocol.)
✓. Measurable disease, as indicated by one or more of the following:
✓. Males and females ≥ 18 years of age
✓. Life expectancy of more than three months
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (see Appendix B)
✓.Adequate hepatic function, with bilirubin \< 2 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) \< 3 times ULN 9.Absolute neutrophil count (ANC) ≥ 1,000/mm3 Hemoglobin ≥ 8 gm/dL Platelet count ≥ 50,000/ mm3 (≥ 30 × 109/L if myeloma involvement in the bone marrow is \> 50%)
Exclusion criteria
✕. Subjects with non-secretory or hyposecretory multiple myeloma, defined as \<0.5 g/dL M-protein in serum and \<200 mg/24 hr Bence Jones protein in urine and serum free light chain \<10mg/dL (\<100 mg/L) and no measurable plasmacytoma
✕. Corticosteroid therapy in a dose equivalent to dexamethasone ≥ 4 mg/day or prednisone ≥20 mg/day within 3 weeks prior to first dose
What they're measuring
1
Safety and dose of carfilzomib, lenalidomide, vorinostat and dexamethasone for MM
Timeframe: Within 30 days of the last administration of study treatment
✕. Chemotherapy with approved or investigative anticancer therapeutics, including steroid therapy dose as defined above, within 2 weeks prior to first dose
✕. Radiation therapy within 1 week prior to first dose, Immunotherapy within 3 weeks prior to first dose . Planned radiation therapy that occurs after the start of treatment