Multiple Myeloma
Conditions
Brief summary
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.
Interventions
DRUGElotuzumab
DRUGLenalidomide
DRUGDexamethasone
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Documented evidence of active multiple myeloma: * Newly diagnosed, not candidate for transplant * Relapsed/refractory who have received up to 3 prior lines of therapy * Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled: * Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide * Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)
Exclusion criteria
* Target Disease Exceptions * Plasma cell leukemia * Monoclonal gammopathy of undetermined significance (MGUS) * Smoldering Myeloma * Primary amyloidosis * Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 | From Day 1 to End of cycle 2 treatment (approximately 56 days) | Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period | Date of first dose up to 60 days post last dose (approximately 4 years) | An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death. |
Countries
United States
Participant flow
Recruitment details
84 participants were enrolled. 70 participants were randomized and treated. Reasons for non-randomization/non-treatment were 10 no longer met study criteria, 1 withdrew consent, and 3 due to other reasons.
Participants by arm
| Arm | Count |
|---|---|
| E-Ld E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative reason by Sponsor | 9 |
| Overall Study | Adverse Event unrelated to study drug | 9 |
| Overall Study | Death | 1 |
| Overall Study | Disease Progression | 23 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Maximum clinical benefit | 3 |
| Overall Study | Other reasons | 11 |
| Overall Study | Study drug toxicity | 7 |
| Overall Study | Subject request to discontinue treatment | 3 |
| Overall Study | Subject withdrew consent | 3 |
Baseline characteristics
| Characteristic | E-Ld |
|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 9.4 |
| Age, Customized < 75 years | 49 Participants |
| Age, Customized >= 75 years | 21 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 34 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 32 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized White | 57 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 70 |
| other Total, other adverse events | 68 / 70 |
| serious Total, serious adverse events | 35 / 70 |
Outcome results
Primary
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Time frame: From Day 1 to End of cycle 2 treatment (approximately 56 days)
Population: All Treated Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E-Ld | Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 | 0 Participants |
Secondary
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
Time frame: Date of first dose up to 60 days post last dose (approximately 4 years)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| E-Ld | Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period | # of participants with any grade infusion reaction | 3 Participants |
| E-Ld | Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period | # of participants with G3/4 infusion reaction | 1 Participants |