Phase 2
Completed N=82
Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
Source: ClinicalTrials.gov NCT02272803 ↗Enrolled (actual)
82
Serious AEs
64.6%
Results posted
Mar 2018
Primary outcomePrimary: Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld) — 87.5 Percentage of participants
Summary
The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld) |
87.5 | — |
| SECONDARY Objective Response Rate (ORR) |
92.5; 73.8 | — |
| SECONDARY Progression Free Survival (PFS) |
NA; 43.33 | — |
| SECONDARY Progression Free Survival (PFS) Rate |
0.87; 0.89; 0.67; 0.60; 0.61; 0.56 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Newly diagnosed with symptomatic Multiple Myeloma (MM)
- Have not received any prior systemic anti-myeloma therapy
- Have measurable disease
- Are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-116 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old
Exclusion Criteria
- Non-secretory myeloma
- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Active plasma cell leukemia
- Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Data sourced from ClinicalTrials.gov (NCT02272803). 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.