Trial · NCT03411031
Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
NCT03411031, Phase 2, Terminated, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2022-04-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide. Trials, record NCT03411031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03411031
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
- NCT number
- NCT03411031
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Multiple Myeloma
- Interventions
- Elotuzumab, Lenalidomide, Dexamethasone
- First posted
- 2018-01-25
- Last updated
- 2023-03-29
- Results first posted
- 2022-04-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression Free Survival (PFS) | An average of 8 months | Progression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval. |
| Secondary | Overall Response | Up to 60 days post last study treatment | Overall response with elotuzumab and lenalidomide for each study arm. Overall Response is defined as best Overall Response, as Complete Response or Partial Response. Response will be assessed per the uniform response criteria of the International Myeloma Working Group(IMWG). Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle. Complete Response= Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates; Partial Response= ≥50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by ≥90% or to \<200 mg per 24 h; |
| Secondary | Minimum Response (MR) | Up to 60 days post last study treatment | Minimum response (MR) or better with elotuzumab and lenalidomide for each study arm. The Consensus on Uniform Reporting of Response will be used to evaluate response. Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Progression Free Survival (PFS) | An average of 8 months | percentage of participants | NUMBER | |
| SECONDARY | Overall Response | Up to 60 days post last study treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Minimum Response (MR) | Up to 60 days post last study treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Progression Free Survival (PFS) | A: Elotuzumab + Lenalidomide at 25 mg | 11.1 | 95% Confidence Interval 0.1 to 38.8 | percentage of participants | |
| Percentage of Participants With Progression Free Survival (PFS) | B: Elotuzumab + Lenalidomide at 10 mg | 22.2 | 95% Confidence Interval 3.4 to 51.3 | percentage of participants | |
| Overall Response | A: Elotuzumab + Lenalidomide at 25 mg | 1 | Participants | ||
| Overall Response | B: Elotuzumab + Lenalidomide at 10 mg | 2 | Participants | ||
| Minimum Response (MR) | A: Elotuzumab + Lenalidomide at 25 mg | 2 | Participants | ||
| Minimum Response (MR) | B: Elotuzumab + Lenalidomide at 10 mg | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A: Elotuzumab + Lenalidomide at 25 mg | 9 | |
| Overall Study | STARTED | B: Elotuzumab + Lenalidomide at 10 mg | 9 | |
| Overall Study | COMPLETED | A: Elotuzumab + Lenalidomide at 25 mg | 9 | |
| Overall Study | COMPLETED | B: Elotuzumab + Lenalidomide at 10 mg | 9 | |
| Overall Study | NOT COMPLETED | A: Elotuzumab + Lenalidomide at 25 mg | 0 | |
| Overall Study | NOT COMPLETED | B: Elotuzumab + Lenalidomide at 10 mg | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Fatigue | General disorders | A: Elotuzumab + Lenalidomide at 25 mg | 1 | 9 | 2 |
| other | Fatigue | General disorders | B: Elotuzumab + Lenalidomide at 10 mg | 0 | 9 | 0 |
| other | Neutrophil count decreased | Investigations | A: Elotuzumab + Lenalidomide at 25 mg | 0 | 9 | 0 |
| other | Neutrophil count decreased | Investigations | B: Elotuzumab + Lenalidomide at 10 mg | 1 | 9 | 1 |
| other | Syncope | Nervous system disorders | A: Elotuzumab + Lenalidomide at 25 mg | 1 | 9 | 1 |
| other | Syncope | Nervous system disorders | B: Elotuzumab + Lenalidomide at 10 mg | 0 | 9 | 0 |
| serious | Fever | General disorders | A: Elotuzumab + Lenalidomide at 25 mg | 1 | 9 | 1 |
| serious | Fever | General disorders | B: Elotuzumab + Lenalidomide at 10 mg | 0 | 9 | 0 |
| serious | Non-cardiac chest pain | Cardiac disorders | A: Elotuzumab + Lenalidomide at 25 mg | 1 | 9 | 1 |
| serious | Non-cardiac chest pain | Cardiac disorders | B: Elotuzumab + Lenalidomide at 10 mg | 0 | 9 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: Elotuzumab + Lenalidomide at 25 mg | 0 | 9 |
| Total, all-cause mortality | B: Elotuzumab + Lenalidomide at 10 mg | 0 | 9 |
| Total, other adverse events | A: Elotuzumab + Lenalidomide at 25 mg | 2 | 9 |
| Total, other adverse events | B: Elotuzumab + Lenalidomide at 10 mg | 1 | 9 |
| Total, serious adverse events | A: Elotuzumab + Lenalidomide at 25 mg | 3 | 9 |
| Total, serious adverse events | B: Elotuzumab + Lenalidomide at 10 mg | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A: Elotuzumab + Lenalidomide at 25 mg vs B: Elotuzumab + Lenalidomide at 10 mg: Minimum Response (MR) | Trial comparisons |
| A: Elotuzumab + Lenalidomide at 25 mg vs B: Elotuzumab + Lenalidomide at 10 mg: Overall Response | Trial comparisons |
| A: Elotuzumab + Lenalidomide at 25 mg vs B: Elotuzumab + Lenalidomide at 10 mg: deaths from any cause | Trial comparisons |
| A: Elotuzumab + Lenalidomide at 25 mg vs B: Elotuzumab + Lenalidomide at 10 mg: serious adverse events | 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/NCT03411031
GET https://conductscience.org/api/trials/v1/NCT03411031/registered