An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
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| ClinicalTrials.gov Identifier: NCT02654132 |
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Recruitment Status :
Completed
First Posted : January 13, 2016
Results First Posted : June 3, 2019
Last Update Posted : November 1, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 117 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3) |
| Actual Study Start Date : | March 18, 2016 |
| Actual Primary Completion Date : | January 17, 2018 |
| Actual Study Completion Date : | October 21, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Elotuzumab Arm
Biological:Elotuzumab (BMS-901608; HuLuc63)
Drug: Pomalidomide •Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone
Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak |
Drug: Elotuzumab Drug: Pomalidomide Other Name: Pomalyst Drug: Dexamethasone Other Name: Decadron, Dexamethasone, Intensol, Dexpak, Taperpak |
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Active Comparator: Control Arm
Drug: Pomalidomide • Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: • Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22 Subjects > 75 years old: • Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22, Other Names:
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Drug: Pomalidomide
Other Name: Pomalyst Drug: Dexamethasone Other Name: Decadron, Dexamethasone, Intensol, Dexpak, Taperpak |
- Progression Free Survival (PFS) [ Time Frame: From randomization to date of progression or death (up to approximately 21 months) ]
PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following:
1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder
- Objective Response Rate (ORR) [ Time Frame: From first dose to disease progression (up to approximately 21 months) ]
ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment
- CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow
- sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
- VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour
- PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.
- Overall Survival (OS) [ Time Frame: From randomization to death (up to approximately 52 months) ]OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination
- Documented refractory or relapsed and refractory multiple myeloma
- Refractory to proteosome inhibitor and lenalidomide, and to last treatment
- Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment
- Measurable disease at screening
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion Criteria:
- Active plasma cell leukemia
- Prior treatment with pomalidomide
- Unable to tolerate thromboembolic prophylaxis while on the study
- Prior autologous stem cell transplant within 12 weeks
- Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654132
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02654132 |
| Other Study ID Numbers: |
CA204-125 2014-003282-19 ( EudraCT Number ) |
| First Posted: | January 13, 2016 Key Record Dates |
| Results First Posted: | June 3, 2019 |
| Last Update Posted: | November 1, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Dexamethasone acetate Pomalidomide Elotuzumab BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |