A Study of the Combination Vorinostat With Lenalidomide, Bortezomib and Dexamethasone for Patients With Newly Diagnosed Multiple Myeloma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT01038388
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    1.3mg/m² given IV or subcutaneously
  • Lenalidomide — DRUG
    25 mg given PO
  • Dexamethasone — DRUG
    20 mg given PO
  • Vorinostat — DRUG
    100, 200, or 300 mg given PO

Study Details

The purpose of the study is to evaluate the clinical effectiveness and side effects of the vorinostat, bortezomib, lenalidomide, and dexamethasone investigational combination.

Key Dates

Start date
Jan 15, 2010
Status verified
Nov 2021
Primary completion
Aug 5, 2021
Completion
Aug 5, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bortezomib, lenalidomide, dexamethasone, vorinostat
    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11; lenalidomide by mouth once a day on days 1-14; dexamethasone by mouth once a day on days 1, 2, 4, 5, 8, 9, 11, and 12; and vorinostat by mouth on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After 8 courses, patients may receive maintenance therapy comprising lenalidomide by mouth once a day on days 1-21, dexamethasone by mouth once a day on days 1, 2, 8, and 9, and bortezomib IV over 3-5 seconds or subcutaneously on days 1 and 8. Courses may repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

To determine the maximum tolerated dose (MTD) and recommended phase II doses (RP2D) of vorinostat in combination with lenalidomide, bortezomib, and dexamethasone. [ Time Frame: Every 3 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Winship Cancer InstituteAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Emory University Winship Cancer Institute· Atlanta, GA

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