Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03411031 |
Recruitment Status :
Active, not recruiting
First Posted : January 25, 2018
Results First Posted : April 14, 2022
Last Update Posted : April 19, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: Elotuzumab Drug: Lenalidomide Drug: Dexamethasone | Phase 2 |
This is a randomized parallel 2-cohort phase 2 study of elotuzumab given at 10 mg/kg weekly during induction in combination with lenalidomide (either 25 mg or 10 mg) in patients with multiple myeloma who progress or relapse serologically while on single agent lenalidomide maintenance.
The combination therapy with elotuzumab and lenalidomide will be continued until further progression of myeloma (based on response criteria) or intolerability.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Parallel Phase 2 Study of Elotuzumab Plus Lenalidomide (Elo/Rev) for the Treatment of Serologic Relapse/Progression While on Lenalidomide Maintenance for Multiple Myeloma |
Actual Study Start Date : | October 4, 2018 |
Actual Primary Completion Date : | February 18, 2021 |
Estimated Study Completion Date : | April 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A: Elotuzumab + Lenalidomide at 25 mg
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule. |
Drug: Elotuzumab
Elotuzumab according to dosing schedule outlined in treatment arms.
Other Names:
Drug: Lenalidomide Lenalidomide according to dosing schedule outlined in treatment arms.
Other Names:
Drug: Dexamethasone Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert. Other Name: Decadron |
Active Comparator: B: Elotuzumab + Lenalidomide at 10 mg
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule. |
Drug: Elotuzumab
Elotuzumab according to dosing schedule outlined in treatment arms.
Other Names:
Drug: Lenalidomide Lenalidomide according to dosing schedule outlined in treatment arms.
Other Names:
Drug: Dexamethasone Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert. Other Name: Decadron |
- Percentage of Participants With Progression Free Survival (PFS) [ Time Frame: An average of 8 months ]Progression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval.
- Overall Response Rate (ORR) [ Time Frame: Up to 60 days post last study treatment ]Overall response rate (ORR) with elotuzumab and lenalidomide for each study arm. The Consensus on Uniform Reporting of Response will be used to evaluate response. Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle.
- Minimum Response (MR) [ Time Frame: Up to 60 days post last study treatment ]Minimum response (MR) or better rate with elotuzumab and lenalidomide for each study arm. The Consensus on Uniform Reporting of Response will be used to evaluate response. Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle.
- Time to Next Treatment (TTNT) [ Time Frame: Up to 60 days post last study treatment ]Time to next treatment (TTNT): Median time free of treatment per study arm.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with multiple myeloma who demonstrate evidence of serologic relapse/progression while on lenalidomide maintenance given as part of first line therapy (including upfront high-dose chemotherapy followed by autologous hematopoietic cell transplantation (HCT)) without symptomatic relapse/progression. Lenalidomide maintenance is defined as single agent lenalidomide therapy of any doses up to 10 mg PO daily for up to 28 days (28-day cycle).
- Male or female patients aged ≥ 18 years old
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- Measurable disease as outlined in protocol guidelines
- Participants must meet laboratory criteria as outlined in protocol guidelines
Exclusion Criteria:
- Prior Elotuzumab
-
Patients with clinical relapse/progression as per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma defined as one or more of the following criteria:
- Development of new soft tissue plasmacytomas or bone lesions (osteoporotic fractures do not constitute progression)
- Definite increase in the size of existing plasmacytomas or bone lesions. A definite increase is defined as a 50% (and ≥1 cm) increase as measured serially of the measurable lesion
- Hypercalcemia (>11 mg/dL);
- Decrease in hemoglobin of ≥2 g/dL not related to therapy or other non-myeloma-related conditions;
- Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and attributable to myeloma
- Hyperviscosity related to serum paraprotein
- Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy testing within 7 days prior to the administration of drug.
- Male patients whose sexual partners are WOCBP not using effective birth control
- Patients with a prior malignancy with in the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)
- Patients with known positivity for human immunodeficiency virus (HIV)) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- Patients with a diagnosis of POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)

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): NCT03411031
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Melissa Alsina, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Documents provided by H. Lee Moffitt Cancer Center and Research Institute:
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT03411031 |
Other Study ID Numbers: |
MCC-19197 NCI-2018-00891 ( Other Identifier: NCI ) |
First Posted: | January 25, 2018 Key Record Dates |
Results First Posted: | April 14, 2022 |
Last Update Posted: | April 19, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
lenalidomide maintenance hematopoietic cell transplantation serologic relapse |
Multiple Myeloma Neoplasms, Plasma Cell Recurrence 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 |
Disease Attributes Pathologic Processes Thalidomide Dexamethasone Lenalidomide Elotuzumab Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |