Trial Outcomes & Findings for Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients With Refractory Multiple Myeloma (NCT NCT03713294)

Last Updated: 2025-06-24

Results Overview

Overall response rate (ORR) defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent CR (sCR). CR and sCR are defined in Outcome 2. VGPR requires: serum and urine M-protein detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-protein and urine M-protein \<100 mg/24 h. If the only measurable disease is FLC, a \>90% reduction in the difference between involved and uninvolved FLC levels. PR requires: if present at baseline, \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \<200 mg/24hrs. If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and uninvolved FLC levels. If the only measurable disease is BM, a ≥ 50% reduction in BM PCs (provided the baseline PCs was ≥ 30%). If present at baseline, ≥ 50% reduction in the size (SPD) of soft tissue plasmacytomas.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

3 years

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients With Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=37 Participants Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Treatment n=37 Participants Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Response Rate	0.35 proportion of participants

SECONDARY outcome

Timeframe: 3 years

Will be estimated by the number of patients who achieve a sCR or CR divided by the total number of evaluable patients. Complete Response (CR) is defined by all of the following: negative immunofixation of serum and urine; disappearance of any soft tissue plasmacytoma; \<5% PCs in bone marrow; and if the only measurable disease is Free Light Chain (FLC), a normal FLC ratio. Stringent Complete Response (sCR) is defined as CR plus normal FLC ratio and absence of clonal circulating plasma cells (PCs) immunohistochemistry or 2- to 4- color flow cytometry.

Outcome measures

Outcome measures
Measure	Treatment n=37 Participants Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Percentage of Patients Achieving CR	0 percentage of patients who achieve CR

SECONDARY outcome

Timeframe: 3 years

PFS is defined as the time from registration to time of disease progression or death due to any cause.

Outcome measures

Outcome measures
Measure	Treatment n=37 Participants Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival (PFS)	3.7 months Interval 2.9 to 11.1

SECONDARY outcome

Timeframe: 37 months

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The table of these events is located in the adverse events section of this report.

Outcome measures

Outcome measures
Measure	Treatment n=37 Participants Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Count of Patients That Experienced a Grade 3 or Greater Adverse Events	27 Participants

SECONDARY outcome

Timeframe: 62 months

OS is defined as the time from registration to death due to any cause.

Outcome measures

Outcome measures
Measure	Treatment n=37 Participants Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS)	56.7 Months Interval 27.2 to Not enough events occurred to determine upper limit.

Adverse Events

Treatment

Serious events: 12 serious events

Other events: 37 other events

Deaths: 18 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=37 participants at risk Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Blood and lymph sys disorders - Oth Spec	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Cardiac disorders Cardiac arrest	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Cardiac disorders Sinus bradycardia	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Cardiac disorders Ventricular arrhythmia	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Cardiac disorders Ventricular tachycardia	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Gastrointestinal disorders Colitis	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Gastrointestinal disorders Nausea	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Gastrointestinal disorders Small intestinal obstruction	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Gastrointestinal disorders Vomiting	5.4% 2/37 • Number of events 2 • Adverse events were collected over 37 months and mortality was collected over 62 months.
General disorders Edema limbs	2.7% 1/37 • Number of events 2 • Adverse events were collected over 37 months and mortality was collected over 62 months.
General disorders Edema trunk	2.7% 1/37 • Number of events 2 • Adverse events were collected over 37 months and mortality was collected over 62 months.
General disorders Fatigue	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Infections and infestations Endocarditis infective	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Infections and infestations Lung infection	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Infections and infestations Skin infection	5.4% 2/37 • Number of events 2 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Infections and infestations Urinary tract infection	2.7% 1/37 • Number of events 2 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Infections and infestations Uterine infection	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Injury, poisoning and procedural complications Fall	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Investigations Investigations - Other, specify	5.4% 2/37 • Number of events 2 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Metabolism and nutrition disorders Hypercalcemia	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Musculoskeletal and connective tissue disorders Flank pain	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Nervous system disorders Dizziness	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.4% 2/37 • Number of events 3 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.4% 2/37 • Number of events 2 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Vascular disorders Thromboembolic event	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.

Other adverse events

Other adverse events
Measure	Treatment n=37 participants at risk Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	89.2% 33/37 • Number of events 264 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Blood and lymphatic system disorders Blood and lymph sys disorders - Oth Spec	5.4% 2/37 • Number of events 2 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Endocrine disorders Endocrine disorders - Other, specify	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Gastrointestinal disorders Constipation	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Gastrointestinal disorders Gastrointestinal pain	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
General disorders Edema face	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
General disorders Fatigue	73.0% 27/37 • Number of events 247 • Adverse events were collected over 37 months and mortality was collected over 62 months.
General disorders Gen disord and admin site conds-Oth spec	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Immune system disorders Allergic reaction	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Infections and infestations Lung infection	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Infections and infestations Upper respiratory infection	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Infections and infestations Urinary tract infection	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Investigations Investigations - Other, specify	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Investigations Lymphocyte count decreased	10.8% 4/37 • Number of events 8 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Investigations Lymphocyte count increased	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Investigations Neutrophil count decreased	70.3% 26/37 • Number of events 181 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Investigations Platelet count decreased	73.0% 27/37 • Number of events 102 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Investigations White blood cell decreased	21.6% 8/37 • Number of events 19 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Psychiatric disorders Psychiatric disorders - Other, specify	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Renal and urinary disorders Renal and urinary disorders - Oth spec	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Renal and urinary disorders Urinary frequency	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Respiratory, thoracic and mediastinal disorders Cough	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Skin and subcutaneous tissue disorders Pruritus	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.1% 3/37 • Number of events 3 • Adverse events were collected over 37 months and mortality was collected over 62 months.
Skin and subcutaneous tissue disorders Skin and subcut tissue disord - Oth spec	2.7% 1/37 • Number of events 1 • Adverse events were collected over 37 months and mortality was collected over 62 months.

Additional Information

Sikander Ailawadhi

Mayo Clinic

Phone: 904/953-6468

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place