Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
NCT ID: NCT00111813
Last Updated: 2015-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2005-09-30
2011-05-31
Brief Summary
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* To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
* To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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vorinostat 200 mg + bortezomib 0.7 mg/m^2
Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
vorinostat 200 mg + bortezomib 0.9 mg/m^2
Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
vorinostat 300 mg + bortezomib 1.3 mg/m^2
Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle.
vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
vorinostat 400 mg + bortezomib 0.9 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
vorinostat 400 mg + bortezomib 1.1 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
vorinostat 400 mg + bortezomib 1.3 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Interventions
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vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities)
* Adequate bone marrow reserve
* Adequate hepatic and renal function
* Ability to swallow capsules
* 3 weeks or more since prior chemotherapy and have recovered from prior toxicities
Exclusion Criteria
* Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism
* Participants with other active/uncontrolled clinically significant illness
* Pregnant or nursing female participants
* Participants who received bortezomib within 3 months of start of this trial
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Weber DM, Graef T, Hussein M, Sobecks RM, Schiller GJ, Lupinacci L, Hardwick JS, Jagannath S. Phase I trial of vorinostat combined with bortezomib for the treatment of relapsing and/or refractory multiple myeloma. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):319-24. doi: 10.1016/j.clml.2012.07.007.
Other Identifiers
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2005_018
Identifier Type: -
Identifier Source: secondary_id
0683-015
Identifier Type: -
Identifier Source: org_study_id
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