Study of Vorinostat (MK0683), an Histone Deacetylase (HDAC) Inhibitor in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (MK-0683-095)
CompletedPhase 2Results postedLast updated 1 April 2021
What this trial tests
Phase 2 trial testing Vorinostat in Relapsed or Refractory Multiple Myeloma in 143 participants. Completed in 9 April 2012.
18 and older, any sex, with Relapsed or Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (RR)Primary· 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-
Group
Value
95% CI
Vorinostat + Bortezomib
11.3
6.6 – 17.7
Number of Participants Who Experienced an Adverse Event (AE)Secondary· 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.
Group
Value
95% CI
Vorinostat + Bortezomib
142
Number of Participants Who Discontinued Study Treatment Due to an AESecondary· 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.
Group
Value
95% CI
Vorinostat + Bortezomib
28
Time To Disease Progression (TTP) as Determined by IAC Per EBMT CriteriaSecondary· 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
Group
Value
95% CI
Vorinostat + Bortezomib
3.47
2.53 – 4.57
TTP as Assessed by Investigator Per EBMT CriteriaSecondary· 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 abso
Group
Value
95% CI
Vorinostat + Bortezomib
3.07
2.37 – 4.33
Progression-Free Survival (PFS) as Determined by IAC Per EBMT CriteriaSecondary· 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 in
Group
Value
95% CI
Vorinostat + Bortezomib
3.13
2.40 – 4.33
PFS as Assessed by Investigator Per EBMT CriteriaSecondary· 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 abso
Group
Value
95% CI
Vorinostat + Bortezomib
2.83
2.17 – 3.77
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Vorinostat + Bortezomib
11.23
8.47 – 14.43
Adverse events — posted to ClinicalTrials.gov
Time frame: Up tp approximately 22 months for non-serious adverse events (AEs). Up to approximately 40 months for serious AEs and all-cause mortality..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Vorinostat + Bortezomib
Serious: 92/142 (65%)
Deaths: 85/143
Serious adverse events (103 terms)
Reaction
System
Vorinostat + Bortezomib
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate the clinical activity of vorinostat in combination with bortezomib in participants with relapsed or refractory multiple myeloma after at least 2 prior treatment regimens. The primary objective is to define the objective response rate (RR) associated with the administration of vorinostat in combination with bortezomib to patients with relapsed and refractory multiple myeloma after at least 2 prior treatment regimens. The primary hypothesis of the study is the administration of vorinostat in combination with bortezomib will result in a clinically meaningful rate of objective response.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07261241 — NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab
· Phase 2
· not yet recruiting
NCT05608369 — Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC
· Phase 2
· withdrawn
NCT04339751 — Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s Disease
· Phase 2
· withdrawn
NCT06145633 — Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
NCT05700630 — Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia
· Phase 1
· withdrawn
Other recruiting trials for Relapsed or Refractory Multiple Myeloma
Currently open trials in the same condition.
NCT07369895 — Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT07116616 — A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 1, PHASE2
· recruiting
NCT07312188 — A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT06604715 — A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT06574568 — A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 1 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00773838.