Vorinostat,Lenalinomide and Dexamethasone in Multiple Myeloma Refractory to Previous Lenalinomide Containing Regimens

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT01502085
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vorinostat, Lenalinomide and Dexamethasone — DRUG
    Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 \* Lenalidomide dose for patients with renal impairment (CrCL\<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above

Study Details

Phase IIb clinical trial to determine if resistance to a lenalidomide containing regimen can be overcome by the addition of vorinostat, in patients with relapsed and refractory multiple myeloma.

Key Dates

Start date
Dec 31, 2011
Status verified
Mar 2026
Primary completion
Dec 31, 2015
Completion
May 31, 2016

Study Design

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

Arms

  • Experimental: Vorinostat, Lenalinomide, Dexamethasone
    Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 \* Lenalidomide dose for patients with renal impairment (CrCL\<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above

Primary Outcome Measure

Overall Response Rate (PR or Better) of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed/Refractory MM Refractory to a Previous Lenalidomide Containing Regimen [ Time Frame: On treatment portion of study is completed after 12 cycles (each cycle is 28 days in duration) and one month of follow up. Patients may be followed for up to two years after last dose of lenalidomide and vorinostat for disease status and survival. ]

Locations (1)

FacilityCityStateZIPSite coordinators
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-

Find similar trials in Hackensack, NJ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
John Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJ

Related Studies