Phase 3
Completed N=748
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
Source: ClinicalTrials.gov NCT01335399 ↗Enrolled (actual)
748
Serious AEs
77.1%
Results posted
Oct 2020
Primary outcomePrimary: Progression-Free Survival (PFS) — 31.38; 29.47 Months — p=0.4358
◆ Published Evidence
Established
47citations · ~12 / year
Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial.
Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
Linked Publications
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Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
31.38; 29.47 | 0.4358 |
| SECONDARY Objective Response Rate (ORR) |
82.9; 79.4 | 0.2232 |
| SECONDARY Overall Survival (OS) |
60.42; 57.56 | 0.8932 |
| SECONDARY Mean Change From Baseline of Pain Severity Score and Pain Interference Score |
0.02; -0.25; 0.33; -0.18 | — |
| SECONDARY Progression Free Survival (PFS) Rate at Specific Time-points |
0.77; 0.76; 0.59; 0.55; 0.46; 0.41 | 0.4358 |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
- Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
- have not received any prior systemic anti-myeloma therapy AND
- have measurable disease AND
- 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 CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old
Exclusion Criteria
- Subjects with non-secretory or oligo-secretory or free light-chain only 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 (NCT01335399) and the linked publication. 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.