Clinical trial · Interventional

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

A Multicenter, Open-Label, Phase I Study of MK-0683 in Combination With Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma

NCT00858234CI-TRIAL-00051185completedPhase 1Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Bortezomib	Drug	Bortezomib	ALIAS
Vorinostat	Drug	Vorinostat	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Vorinostat + Bortezomib
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).
interventionNames
1. Drug: Vorinostat
2. Drug: Bortezomib

Primary outcomes (1)

measure
Number of Participants With Dose-Limiting Toxicity (DLT) During Cycle 1
timeFrame
Up to 21 days
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).

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 20 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTOgawa 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