NCT00858234 · REGISTRY CONDITION SEARCH

Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2021-04-09

The primary purpose of this clinical study is to determine the recommended clinical doses of vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed and/or refractory multiple myeloma (MM). It was hypothesized that administration of vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to permit further study in participants with relapsed and/or refractory MM. Study results are based on data collected up to the data cut-off date of 20-March-2011.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose-Limiting Toxicity (DLT) During Cycle 1

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outcome · POSTED

Number of Participants With an Adverse Event (AE)

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outcome · POSTED

Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Vorinostat Administered With Bortezomib on Days 1 and 11

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * is ≥20 years of age. * has an established diagnosis of MM based on the myeloma diagnostic criteria * has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen * has adequate organ function Exclusion Criteria: * has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation during the study * has known hypersensitivity to any components of vorinostat or bortezomib * has active hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus (HIV) positive * has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors
healthy Volunteers: false
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants undergo up to 3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg once daily \[QD\] on Days 1 through 14) + bortezomib (1.3 mg/m\^2 intravenous \[IV\] on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).
intervention Names
Drug: Vorinostat
Drug: Bortezomib
label
Vorinostat + Bortezomib
type
EXPERIMENTAL

interventions

arm Group Labels
Vorinostat + Bortezomib
description
Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food.
name
Vorinostat
other Names
MK-0683
ZOLINZA™
type
DRUG
arm Group Labels
Vorinostat + Bortezomib
description
Bortezomib (1.0 or 1.3 mg/m\^2) intravenous infusion.
name
Bortezomib
other Names
VELCADE®
type
DRUG

Study design

allocation

intervention Model

SEQUENTIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 9
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
The number of participants with ≥1 AE is reported. An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product(s), whether or not considered related to the use of the product(s).
measure
Number of Participants With an Adverse Event (AE)
time Frame
Up to 346 days (up to 30 days after the final dose of study treatment)
description
The AUC0-24hr of vorinostat in plasma on Days 1 and 11 is reported in participants who also received bortezomib.
measure
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Vorinostat Administered With Bortezomib on Days 1 and 11
time Frame
Predose and 0.8, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 1 and 11

primary Outcomes

description
The number of participants with ≥1 DLT during Cycle 1 is reported. A DLT is defined as an event considered by the investigator to be related to study treatment, and either: 1) a Grade 3 or 4 non-hematologic event (except for manageable toxicity by supportive care or non-prohibited therapies, or a transient increase in alanine aminotransferase \[ALT\]/aspartate aminotransferase \[AST\]); or 2) a Grade 4 hematologic toxicity except neutropenia or hemoglobin decreased (neutropenia was a DLT if it was Grade 3-4 with fever ≥38.5°C; Grade 3-4 with an infection requiring antibiotic/antifungal therapy; or Grade 4 and lasting ≥5 days).
measure
Number of Participants With Dose-Limiting Toxicity (DLT) During Cycle 1
time Frame
Up to 21 days

Full study description

brief Summary: The primary purpose of this clinical study is to determine the recommended clinical doses of vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed and/or refractory multiple myeloma (MM). It was hypothesized that administration of vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to permit further study in participants with relapsed and/or refractory MM. Study results are based on data collected up to the data cut-off date of 20-March-2011.

Source references

references

citation
Ogawa Y, Ogura M, Tobinai K, Ando K, Suzuki T, Watanabe T, Ohmachi K, Uchida T, Hanson ME, Tanaka Y, Koh Y, Shimamoto T, Hotta T. A phase I study of vorinostat combined with bortezomib in Japanese patients with relapsed or refractory multiple myeloma. Int J Hematol. 2016 Jan;103(1):25-33. doi: 10.1007/s12185-015-1897-7. Epub 2015 Nov 30.
pmid
26619834
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice