NCT00111813 · REGISTRY CONDITION SEARCH

Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

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: 2015-05-21

The purposes of this study are: * 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.

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

Mean Duration of Treatment With Vorinostat

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outcome · POSTED

Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug

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outcome · POSTED

Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib

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outcome · POSTED

Clinical AE Summary

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outcome · POSTED

Laboratory AE Summary

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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: * Adults with refractory or relapsed multiple myeloma * 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 who plan to have a bone marrow transplant within 4 weeks of start of treatment * 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
intervention Names
Drug: vorinostat
Drug: bortezomib
label
vorinostat 200 mg + bortezomib 0.7 mg/m^2
type
EXPERIMENTAL
description
Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
intervention Names
Drug: vorinostat
Drug: bortezomib
label
vorinostat 200 mg + bortezomib 0.9 mg/m^2
type
EXPERIMENTAL
description
Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle.
intervention Names
Drug: vorinostat
Drug: bortezomib
label
vorinostat 300 mg + bortezomib 1.3 mg/m^2
type
EXPERIMENTAL
description
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
intervention Names
Drug: vorinostat
Drug: bortezomib
label
vorinostat 400 mg + bortezomib 0.9 mg/m^2
type
EXPERIMENTAL
description
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
intervention Names
Drug: vorinostat
Drug: bortezomib
label
vorinostat 400 mg + bortezomib 1.1 mg/m^2
type
EXPERIMENTAL
description
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
intervention Names
Drug: vorinostat
Drug: bortezomib
label
vorinostat 400 mg + bortezomib 1.3 mg/m^2
type
EXPERIMENTAL

interventions

arm Group Labels
vorinostat 200 mg + bortezomib 0.7 mg/m^2
vorinostat 200 mg + bortezomib 0.9 mg/m^2
vorinostat 300 mg + bortezomib 1.3 mg/m^2
vorinostat 400 mg + bortezomib 0.9 mg/m^2
vorinostat 400 mg + bortezomib 1.1 mg/m^2
vorinostat 400 mg + bortezomib 1.3 mg/m^2
description
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
name
vorinostat
other Names
MK0683
Zolinza®
Suberoylanilide Hydroxamic Acid (SAHA)
type
DRUG
arm Group Labels
vorinostat 200 mg + bortezomib 0.7 mg/m^2
vorinostat 200 mg + bortezomib 0.9 mg/m^2
vorinostat 300 mg + bortezomib 1.3 mg/m^2
vorinostat 400 mg + bortezomib 0.9 mg/m^2
vorinostat 400 mg + bortezomib 1.1 mg/m^2
vorinostat 400 mg + bortezomib 1.3 mg/m^2
description
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
name
bortezomib
other Names
Velcade
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 34
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity. Progressive disease was defined as: * \>25% increase in the level of serum monoclonal paraprotein. * 25% increase in 24-hour urinary light chain excretion. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy. * Development of new bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia. Intolerable toxicity was based on the clinical judgment of the investigator.
measure
Mean Duration of Treatment With Vorinostat
time Frame
Day 1 to an event causing discontinuation from the study, assessed up to 29 months

secondary Outcomes

description
An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
measure
Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
time Frame
Day 1 to disease progression, toxicity, or death, assessed up to 29 months
description
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
measure
Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib
time Frame
Day 1 to disease progression, toxicity, or death, assessed up to 29 months
description
An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition. A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.
measure
Clinical AE Summary
time Frame
Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)
description
An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition. A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose. A lab (S)AE was any lab value considered clinically significant in the investigator's judgment.
measure
Laboratory AE Summary
time Frame
Day 1 up to disease progression, toxicity, or death, assessed up to 29 months

Full study description

brief Summary: The purposes of this study are: * 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.

Source references

references

citation
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.
pmid
23040438
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice