Trial · NCT01441973
Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
NCT01441973, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2016-01-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma. Trials, record NCT01441973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01441973
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
- NCT number
- NCT01441973
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Smoldering Multiple Myeloma
- Interventions
- Elotuzumab (BMS-901608; HuLuc63)
- First posted
- 2011-09-28
- Last updated
- 2018-01-23
- Results first posted
- 2016-01-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow | From day of last patient, first dose to 6 months | Estimated using linear regression model, with baseline CD56\^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56\^dim cells (% chg from BL in M pro/% chg CD56\^dim cs) |
| Secondary | Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | From day of last patient, first dose to 6 months | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. |
| Secondary | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality | From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months | Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning. |
| Secondary | Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate | cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months | All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included. |
| Secondary | Progression Free Survival (PFS) Rate | Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months) | The probability was estimated from the K-M curve of subjects being alive and without disease progression (modified IMWG criteria) at 2 years from the initiation of study therapy by dose cohort |
| Secondary | Objective Response Rate (ORR) | From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months) | ORR is defined as the number of participants with stringent compete response \[SCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\])/number of participants in arm, expressed as a percentage. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level \<100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to \<200 mg/24 hour |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | From day of last patient, first dose to 6 months | All participants who received at least 1 dose of study drug | Participants | NUMBER |
| PRIMARY | Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow | From day of last patient, first dose to 6 months | All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available). | % chg from BL in M pro/% chg CD56^dim cs | NUMBER |
| SECONDARY | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality | From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months | All participants who received at least 1 dose of study drug | Participants | NUMBER |
| SECONDARY | Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate | cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months | All participants who received at least 1 dose of study drug | Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) Rate | Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months) | All treated participants | Probability of Progression Free Survival | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months) | All treated participants | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, 20 mg/kg | Deaths | 0 | Participants | |
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, 10 mg/kg | Deaths | 0 | Participants | |
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, All Dosages | Deaths | 0 | Participants | |
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, 20 mg/kg | SAEs | 8 | Participants | |
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, 10 mg/kg | SAEs | 7 | Participants | |
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, All Dosages | SAEs | 15 | Participants | |
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, 20 mg/kg | AEs leading to discontinuation | 4 | Participants | |
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, 10 mg/kg | AEs leading to discontinuation | 2 | Participants | |
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, All Dosages | AEs leading to discontinuation | 6 | Participants | |
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions | Elotuzumab, 20 mg/kg | Infusion reactions | 4 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Elotuzumab, 20 mg/kg | 15 | |
| Overall Study | STARTED | Elotuzumab, 10 mg/kg | 16 | |
| Overall Study | COMPLETED | Elotuzumab, 20 mg/kg | 0 | |
| Overall Study | COMPLETED | Elotuzumab, 10 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Elotuzumab, 20 mg/kg | 15 | |
| Overall Study | NOT COMPLETED | Elotuzumab, 10 mg/kg | 16 |
Source ClinicalTrials.gov
Adverse events532
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 | Elotuzumab(E) : 10 mg/kg/Dose | 5 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Elotuzumab(E) : 20 mg/kg/Dose | 2 | 15 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Elotuzumab(E) : 10 mg/kg/Dose | 2 | 16 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Elotuzumab(E) : 20 mg/kg/Dose | 0 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | Elotuzumab(E) : 10 mg/kg/Dose | 2 | 16 | |
| other | Neutropenia | Blood and lymphatic system disorders | Elotuzumab(E) : 20 mg/kg/Dose | 0 | 15 | |
| other | Atrial fibrillation | Cardiac disorders | Elotuzumab(E) : 10 mg/kg/Dose | 2 | 16 | |
| other | Atrial fibrillation | Cardiac disorders | Elotuzumab(E) : 20 mg/kg/Dose | 1 | 15 | |
| other | Cardiac failure congestive | Cardiac disorders | Elotuzumab(E) : 10 mg/kg/Dose | 1 | 16 | |
| other | Cardiac failure congestive | Cardiac disorders | Elotuzumab(E) : 20 mg/kg/Dose | 0 | 15 |
1 to 10 of 532Source ClinicalTrials.gov
See all 532 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Elotuzumab(E) : 10 mg/kg/Dose | ||
| Total, all-cause mortality | Elotuzumab(E) : 20 mg/kg/Dose | ||
| Total, other adverse events | Elotuzumab(E) : 10 mg/kg/Dose | 16 | 16 |
| Total, other adverse events | Elotuzumab(E) : 20 mg/kg/Dose | 15 | 15 |
| Total, serious adverse events | Elotuzumab(E) : 10 mg/kg/Dose | 7 | 16 |
| Total, serious adverse events | Elotuzumab(E) : 20 mg/kg/Dose | 8 | 15 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Elotuzumab(E) : 10 mg/kg/Dose vs Elotuzumab(E) : 20 mg/kg/Dose: 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/NCT01441973
GET https://conductscience.org/api/trials/v1/NCT01441973/results?page=2