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An International, Multicenter, Open-Label Study of Vorinostat (MK0683) in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Relapsed or Refractory Multiple Myeloma

Thank you

Trial Information

An International, Multicenter, Open-Label Study of Vorinostat (MK0683) in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma


The protocol has been amended to incorporate language to indicate the end of the study. The
end of the study is designated as the time when the primary endpoint of 29 responders has
been met, or the time when all patients have discontinued treatment or have been enrolled in
the study for at least 6 months (if the primary endpoint is not reached by this time).
Patients will be allowed to continue on protocol as long as they have not met the criteria
for discontinuation.


Inclusion Criteria:



- Patient is 18 years of age or older

- Patient has an established diagnosis of multiple myeloma based on myeloma diagnostic
criteria

- Patient must have adequate organ function

- Patient is refractory to prior bortezomib regimen and have also been exposed to prior
IMiD (thalidimide or lenalidmide)

- Patient has relapsed and refractory multiple myeloma after at lest 2 prior treatment
regimens

- Patient is relapsed, refractory, intolerant, and/or ineligible (in the opinion of the
investigator) to other therapies including an IMiD (thalidomide OR lenalidomide)

- Patient is refractory to bortezomib (no response on prior bortezomib containing
regimen or progression on or within 60 days of bortezomib containing regimen

Exclusion Criteria:

- Patient has known hypersensitivity to any components of bortezomib or vorinostat

- Patient has had a prior allogeneic bone marrow transplant or plans to undergo any
type of bone marrow transplantation within 4 weeks of the initiation of study therapy

- Patient has known hypersensitivity to any components of bortezomib or vorinostat

- Patient has active Hepatitis B or C, plasma cell leukemia, or is HIV positive

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate associated with the administration of vorinostat in combination with bortezomib

Outcome Time Frame:

21 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MK-0683-095

NCT ID:

NCT00773838

Start Date:

December 2008

Completion Date:

April 2012

Related Keywords:

  • Relapsed or Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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