Phase 2 Completed N=70 Treatment

Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

Source: ClinicalTrials.gov NCT02159365 ↗

Enrolled (actual)

Serious AEs

50.0%

Results posted

Jan 2017

Primary outcomePrimary: Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 — 0 Participants

Summary

To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2	—	—
SECONDARY Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period	3; 1	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02159365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.