Trial · NCT00179647
Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma
NCT00179647, Phase 3, Completed, Celgene Corporation; results first posted 2010-03-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma. Trials, record NCT00179647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00179647
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma
- NCT number
- NCT00179647
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,913 participants, actual
- Lead sponsor
- Celgene Corporation
- Conditions
- Multiple Myeloma
- Interventions
- lenalidomide, dexamethasone
- First posted
- 2005-09-16
- Last updated
- 2010-03-16
- Results first posted
- 2010-03-03
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment. | Median time-on-study=18.3 weeks | Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study. |
| Primary | Overall Incidence of Adverse Events | Median time-on-study=18.3 weeks | Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment. | Median time-on-study=18.3 weeks | |||
| PRIMARY | Overall Incidence of Adverse Events | Median time-on-study=18.3 weeks | Subjects who received study drug | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Incidence of Adverse Events | Lenalidomide | 1877 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenalidomide | 1,913 | |
| Overall Study | COMPLETED | Lenalidomide | 0 | |
| Overall Study | NOT COMPLETED | Lenalidomide | 1,913 |
Source ClinicalTrials.gov
Adverse events479
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 | Lenalidomide | 423 | 1,913 | 606 |
| other | ANOREXIA | Metabolism and nutrition disorders | Lenalidomide | 195 | 1,913 | 221 |
| other | APPETITE DECREASED | Metabolism and nutrition disorders | Lenalidomide | 111 | 1,913 | 118 |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Lenalidomide | 218 | 1,913 | 267 |
| other | ASTHENIA | General disorders | Lenalidomide | 277 | 1,913 | 338 |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | Lenalidomide | 276 | 1,913 | 322 |
| other | CONFUSIONAL STATE | Psychiatric disorders | Lenalidomide | 100 | 1,913 | 116 |
| other | CONSTIPATION | Gastrointestinal disorders | Lenalidomide | 471 | 1,913 | 540 |
| other | CONTUSION | Skin and subcutaneous tissue disorders | Lenalidomide | 123 | 1,913 | 154 |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Lenalidomide | 301 | 1,913 | 349 |
1 to 10 of 479Source ClinicalTrials.gov
See all 479 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide | ||
| Total, other adverse events | Lenalidomide | 1,877 | 1,913 |
| Total, serious adverse events | Lenalidomide | 878 | 1,913 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19332768 | DERIVED |
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.
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/NCT00179647
GET https://conductscience.org/api/trials/v1/NCT00179647/events?page=2