Trial · NCT00773747
Study of Vorinostat (MK-0683) or Placebo, in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-088 AMN)
NCT00773747, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-04-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Vorinostat (MK-0683) or Placebo, in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-088 AMN). Trials, record NCT00773747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00773747
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vorinostat (MK-0683) or Placebo, in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-088 AMN)
- NCT number
- NCT00773747
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 637 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Multiple Myeloma
- Interventions
- Vorinostat, bortezomib, placebo to vorinostat
- First posted
- 2008-10-16
- Last updated
- 2021-04-30
- Other registries' IDs
- eudract:2008-003752-30
- Results first posted
- 2021-04-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From randomization to event of disease progression or death assessed up to 32 months (final study analysis) | Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded). Response to study therapy was assessed using European Blood and Marrow Transplantation Group (EBMT) Criteria. A stratified Cox proportional hazards model was used with Efron's likelihood approximation to account for ties in event times. |
| Secondary | Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs) | Up to 722 days | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. Grades come from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Per protocol, clinical and laboratory AEs are presented as a combined total for each grade. |
| Secondary | Overall Survival | From randomization up to 32 months (final study analysis) | Overall survival was measured from the start of the treatment to death due to any cause. Overall Survival is represented as the number of deaths per 100-person- months and was computed by dividing the number of participants with an event of death that occurred during the study follow-up period by the total duration of follow-up (in 100 months) for all the participants in each cohort since participants had different lengths of follow-up. |
| Secondary | Time to Progression | Baseline and at the end of each 21-day Cycle assessed up to 32 months (final study analysis) | Time to progression was measured from the start of the treatment to the time when the criteria for progression was met or death due to myeloma (whichever is first recorded). Response to study therapy was assessed using European Blood and Marrow Transplantation Group (EBMT) Criteria. A stratified Cox proportional hazards model was used with Efron's likelihood approximation to account for ties in event times. |
| Secondary | Objective Response Rate | Baseline and at the end of each 21-day Cycle assessed up to 32 months (final study analysis) | Objective response rate was measured as the proportion of patients who achieved a confirmed partial response or better during the course of the study. Response to study therapy was assessed using EBMT Criteria and confirmed by Independent Adjudication Review. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | From randomization to event of disease progression or death assessed up to 32 months (final study analysis) | The analysis population includes all randomized participants. | Months | MEDIAN |
| SECONDARY | Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs) | Up to 722 days | The analysis population includes all randomized participants who received ≥1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | From randomization up to 32 months (final study analysis) | The analysis population includes all randomized participants. | Events/100-person Months | NUMBER |
| SECONDARY | Time to Progression | Baseline and at the end of each 21-day Cycle assessed up to 32 months (final study analysis) | The analysis population includes all randomized participants. | Months | MEDIAN |
| SECONDARY | Objective Response Rate | Baseline and at the end of each 21-day Cycle assessed up to 32 months (final study analysis) | The analysis population includes all randomized participants who received ≥1 dose of study medication. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Vorinostat + Bortezomib | 7.63 | 95% Confidence Interval 6.87 | Months | |
| Progression-Free Survival (PFS) | Placebo + Bortezomib | 6.83 | 95% Confidence Interval 5.67 | Months | |
| Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs) | Vorinostat + Bortezomib | Grade 3 | 272 | Participants | |
| Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs) | Placebo + Bortezomib | Grade 3 | 240 | Participants | |
| Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs) | Vorinostat + Bortezomib | Grade 4 | 108 | Participants | |
| Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs) | Placebo + Bortezomib | Grade 4 | 85 | Participants | |
| Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs) | Vorinostat + Bortezomib | Grade 5 | 11 | Participants | |
| Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs) | Placebo + Bortezomib | Grade 5 | 17 | Participants | |
| Overall Survival | Vorinostat + Bortezomib | 1.7 | 95% Confidence Interval 1.56 | Events/100-person Months | |
| Overall Survival | Placebo + Bortezomib | 1.9 | 95% Confidence Interval 1.75 | Events/100-person Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vorinostat + Bortezomib | 317 | |
| Overall Study | STARTED | Placebo + Bortezomib | 320 | |
| Overall Study | Treated | Vorinostat + Bortezomib | 315 | |
| Overall Study | Treated | Placebo + Bortezomib | 320 | |
| Overall Study | COMPLETED | Vorinostat + Bortezomib | 20 | |
| Overall Study | COMPLETED | Placebo + Bortezomib | 24 | |
| Overall Study | NOT COMPLETED | Vorinostat + Bortezomib | 297 | |
| Overall Study | NOT COMPLETED | Placebo + Bortezomib | 296 |
Source ClinicalTrials.gov
Adverse events408
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 | 91 | 315 | 198 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Bortezomib | 79 | 320 | 164 |
| other | Leukopenia | Blood and lymphatic system disorders | Vorinostat + Bortezomib | 42 | 315 | 121 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Bortezomib | 32 | 320 | 122 |
| other | Neutropenia | Blood and lymphatic system disorders | Vorinostat + Bortezomib | 112 | 315 | 406 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Bortezomib | 95 | 320 | 300 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vorinostat + Bortezomib | 172 | 315 | 749 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Bortezomib | 106 | 320 | 384 |
| other | Abdominal distension | Gastrointestinal disorders | Vorinostat + Bortezomib | 8 | 315 | 11 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo + Bortezomib | 17 | 320 | 21 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vorinostat + Bortezomib | ||
| Total, all-cause mortality | Placebo + Bortezomib | ||
| Total, other adverse events | Vorinostat + Bortezomib | 312 | 315 |
| Total, other adverse events | Placebo + Bortezomib | 306 | 320 |
| Total, serious adverse events | Vorinostat + Bortezomib | 130 | 315 |
| Total, serious adverse events | Placebo + Bortezomib | 138 | 320 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24055414 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vorinostat + Bortezomib vs Placebo + Bortezomib: serious adverse events |
Source Trial comparisons
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.
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/NCT00773747
GET https://conductscience.org/api/trials/v1/NCT00773747/events?page=2