Trial · NCT00773838

Study of Vorinostat (MK0683), an Histone Deacetylase (HDAC) Inhibitor in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (MK-0683-095)

NCT00773838, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2021-04-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Vorinostat (MK0683), an Histone Deacetylase (HDAC) Inhibitor in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (MK-0683-095). Trials, record NCT00773838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00773838

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Vorinostat (MK0683), an Histone Deacetylase (HDAC) Inhibitor in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (MK-0683-095)
NCT number: NCT00773838
Status: Completed
Phases: Phase 2
Enrollment: 143 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Relapsed or Refractory Multiple Myeloma
Interventions: Vorinostat, Bortezomib, Dexamethasone
First posted: 2008-10-16
Last updated: 2021-04-01
Other registries' IDs: eudract:2008-003753-33
Results first posted: 2021-04-01

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate (RR)	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	Objective RR was defined as percentage (%) of participants with complete response (CR: disappearance of original monoclonal (M) paraprotein from blood \& urine on at least 2 determinations for at least 6 weeks (WKs) by immunofixation studies, \<5% plasma cells in bone marrow on at least 1 determination, no increase in size/number of lytic bone lesions (LBLs) \& disappearance of soft tissue plasmacytomas (STP) for at least 6 WKs on skeletal survey (SS) if available) or partial response (PR: ≥50% reduction in serum M protein for at least 2 determinations 6 WKs apart, if present, reduction in 24-hour urinary light chain excretion by ≥90% or ≤200 mg for at least 2 determinations 6 WKs apart, ≥50% reduction in STP size for at least 6 WKs, \& no increase in size/number of LBLs on SS if available) as assessed by Independent Adjudication Committee (IAC) per European Blood \& Marrow Transplant (EBMT) criteria. To report RR \& 95% confidence intervals (CIs), exact test of binomial parameter was used.
Secondary	Number of Participants Who Experienced an Adverse Event (AE)	Up to approximately 22 months	An AE is 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 is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experienced an AE were reported.
Secondary	Number of Participants Who Discontinued Study Treatment Due to an AE	Up to approximately 18 months	An AE is 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 is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued study treatment due to an AE were reported.
Secondary	Time To Disease Progression (TTP) as Determined by IAC Per EBMT Criteria	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	TTP was defined as the time from allocation to the first documented disease progression (PD) as determined by IAC per EBMT criteria or death due to myeloma, whichever occurred first. PD: \>25% increase in level of serum Mparaprotein, which must also be an absolute increase of at least 5g/L (500 mg/dL) and confirmed on a repeat investigation or 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg/24hour and confirmed on a repeat investigation or \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10% or definitive increase in size of existing LBLs or STP or development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). To report the median TTP (in months) and associated 95% CIs Kaplan-Meier method was used.
Secondary	TTP as Assessed by Investigator Per EBMT Criteria	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	TTP was defined as the time from allocation to the first documented PD as assessed by investigator per EBMT criteria or death due to myeloma, whichever occurred first. PD: \>25% increase in level of serum Mparaprotein, which must also be an absolute increase of at least 5g/L (500 mg/dL) and confirmed on a repeat investigation or 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg/24hour and confirmed on a repeat investigation or \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10% or definitive increase in size of existing LBLs or STP or development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). To report the median TTP (in months) and associated 95% CIs Kaplan-Meier method was used.
Secondary	Progression-Free Survival (PFS) as Determined by IAC Per EBMT Criteria	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	PFS was defined as the time from allocation to the first documents PD as determined by IAC per EBMT criteria or death due to any cause, whichever occurs first. PD: \>25% increase in level of serum M-paraprotein, which must also be an absolute increase of at least 5g/L (500 mg/dL) and confirmed on a repeat investigation or 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg/24hour and confirmed on a repeat investigation or \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10% or definitive increase in size of existing LBLs or STP or development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). To report the median PFS (in months) and associated 95%CIs Kaplan-Meier method was used.
Secondary	PFS as Assessed by Investigator Per EBMT Criteria	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	PFS was defined as the time from allocation to the first documents PD as assessed by investigator per EBMT criteria or death due to any cause, whichever occurs first. PD: \>25% increase in level of serum M-paraprotein, which must also be an absolute increase of at least 5g/L (500 mg/dL) and confirmed on a repeat investigation or 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg/24hour and confirmed on a repeat investigation or \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10% or definitive increase in size of existing LBLs or STP or development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). To report the median PFS (in months) and associated 95%CIs Kaplan-Meier method was used.
Secondary	Overall Survival (OS)	Up to approximately 40 months (through End of Trial data cut-off of 09-Apr-2012)	OS was defined as the time from allocation to death due to any cause. To report the median survival (in months) and the associated 95%CIs were reported using Kaplan-Meier method was used. Participants without documented death at the time of final analysis were censored at the date of the last follow up.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate (RR)	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	All participants who received at least one dose of study treatment	Percentage of Participants	NUMBER
SECONDARY	Number of Participants Who Experienced an Adverse Event (AE)	Up to approximately 22 months	All participants who received at least one dose of study treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Discontinued Study Treatment Due to an AE	Up to approximately 18 months	All participants who received at least one dose of study treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time To Disease Progression (TTP) as Determined by IAC Per EBMT Criteria	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	All participants who received at least one dose of study treatment	Months	MEDIAN
SECONDARY	TTP as Assessed by Investigator Per EBMT Criteria	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	All participants who received at least one dose of study treatment	Months	MEDIAN
SECONDARY	Progression-Free Survival (PFS) as Determined by IAC Per EBMT Criteria	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	All participants who received at least one dose of study treatment	Months	MEDIAN
SECONDARY	PFS as Assessed by Investigator Per EBMT Criteria	Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)	All participants who received at least one dose of study treatment	Months	MEDIAN
SECONDARY	Overall Survival (OS)	Up to approximately 40 months (through End of Trial data cut-off of 09-Apr-2012)	All allocated participants	Months	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Objective Response Rate (RR)	Vorinostat + Bortezomib	11.3	95% Confidence Interval 6.6 to 17.7	Percentage of Participants
Number of Participants Who Experienced an Adverse Event (AE)	Vorinostat + Bortezomib	142		Participants
Number of Participants Who Discontinued Study Treatment Due to an AE	Vorinostat + Bortezomib	28		Participants
Time To Disease Progression (TTP) as Determined by IAC Per EBMT Criteria	Vorinostat + Bortezomib	3.47	95% Confidence Interval 2.53 to 4.57	Months
TTP as Assessed by Investigator Per EBMT Criteria	Vorinostat + Bortezomib	3.07	95% Confidence Interval 2.37 to 4.33	Months
Progression-Free Survival (PFS) as Determined by IAC Per EBMT Criteria	Vorinostat + Bortezomib	3.13	95% Confidence Interval 2.40 to 4.33	Months
PFS as Assessed by Investigator Per EBMT Criteria	Vorinostat + Bortezomib	2.83	95% Confidence Interval 2.17 to 3.77	Months
Overall Survival (OS)	Vorinostat + Bortezomib	11.23	95% Confidence Interval 8.47 to 14.43	Months

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vorinostat + Bortezomib	143
Overall Study	COMPLETED	Vorinostat + Bortezomib	0
Overall Study	NOT COMPLETED	Vorinostat + Bortezomib	143

Source ClinicalTrials.gov

Adverse events156

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Vorinostat + Bortezomib	74	142	231
other	Leukopenia	Blood and lymphatic system disorders	Vorinostat + Bortezomib	25	142	74
other	Neutropenia	Blood and lymphatic system disorders	Vorinostat + Bortezomib	53	142	135
other	Thrombocytopenia	Blood and lymphatic system disorders	Vorinostat + Bortezomib	99	142	582
other	Vision blurred	Eye disorders	Vorinostat + Bortezomib	11	142	13
other	Abdominal discomfort	Gastrointestinal disorders	Vorinostat + Bortezomib	8	142	9
other	Abdominal pain	Gastrointestinal disorders	Vorinostat + Bortezomib	18	142	25
other	Abdominal pain upper	Gastrointestinal disorders	Vorinostat + Bortezomib	12	142	18
other	Constipation	Gastrointestinal disorders	Vorinostat + Bortezomib	35	142	47
other	Diarrhoea	Gastrointestinal disorders	Vorinostat + Bortezomib	74	142	189

1 to 10 of 156Source ClinicalTrials.gov

See all 156 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vorinostat + Bortezomib	85	143
Total, other adverse events	Vorinostat + Bortezomib	140	142
Total, serious adverse events	Vorinostat + Bortezomib	92	142

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27025160	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00773838

GET https://conductscience.org/api/trials/v1/NCT00773838/events?page=2

API reference For AI assistants