Phase 2
Completed N=143
Study of Vorinostat (MK0683), an Histone Deacetylase (HDAC) Inhibitor in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (MK-0683-095)
Source: ClinicalTrials.gov NCT00773838 ↗Enrolled (actual)
143
Serious AEs
64.8%
Results posted
Apr 2021
Primary outcomePrimary: Objective Response Rate (RR) — 11.3 Percentage of Participants — p=0.419
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (RR) |
11.3 | 0.419 |
| SECONDARY Number of Participants Who Experienced an Adverse Event (AE) |
142 | — |
| SECONDARY Number of Participants Who Discontinued Study Treatment Due to an AE |
28 | — |
| SECONDARY Time To Disease Progression (TTP) as Determined by IAC Per EBMT Criteria |
3.47 | — |
| SECONDARY TTP as Assessed by Investigator Per EBMT Criteria |
3.07 | — |
| SECONDARY Progression-Free Survival (PFS) as Determined by IAC Per EBMT Criteria |
3.13 | — |
| SECONDARY PFS as Assessed by Investigator Per EBMT Criteria |
2.83 | — |
| SECONDARY Overall Survival (OS) |
11.23 | — |
Eligibility Criteria
Inclusion Criteria
- Has an established diagnosis of multiple myeloma based on myeloma diagnostic criteria
- Must have adequate organ function
- Is refractory to prior bortezomib regimen and have also been exposed to prior Immunomodulatory imide drugs (IMiD: thalidimide or lenalidmide)
- Has relapsed and refractory multiple myeloma after at least 2 prior treatment regimens
- Has performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Has measurable disease, defined as any quantifiable serum monoclonal (M) protein value and, where applicable, urine light chain of ≥200 mg/24 hours
- Female participants are not pregnant and not breastfeeding, and are not a woman of childbearing potential (WOCBP) or are a WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 30 days after the last dose of study intervention
- Male participants must agree to use approved contraception during the treatment period and for at least 30 days after the last dose of study intervention and refrain from donating sperm during this period
- Is relapsed, refractory, intolerant, and/or ineligible (in the opinion of the investigator) to other therapies including an IMiD (thalidomide or lenalidomide)
- Is refractory to bortezomib (no response on prior bortezomib containing regimen or progression on or within 60 days of bortezomib containing regimen
Exclusion Criteria
- Has known hypersensitivity to any components of bortezomib or vorinostat
- Has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation within 4 weeks of the initiation of study therapy
- Has an active systemic infection
- Has acute diffuse infiltrative pulmonary disease or pericardial disease
- Has known hypersensitivity to any components of bortezomib or vorinostat
- Has active Hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus (HIV) positive
- Has history of a prior malignancy with the exception of cervical intraepithelial neoplasia; non-melanoma skin cancer; adequately treated localized prostate carcinoma with prostate specific antigen (PSA) Grade 2 neuropathy
Data sourced from ClinicalTrials.gov (NCT00773838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.