Trials / Terminated
TerminatedNCT03411031
Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elotuzumab | Elotuzumab according to dosing schedule outlined in treatment arms. |
| DRUG | Lenalidomide | Lenalidomide according to dosing schedule outlined in treatment arms. |
| 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. |
Timeline
- Start date
- 2018-10-04
- Primary completion
- 2021-02-18
- Completion
- 2021-11-04
- First posted
- 2018-01-25
- Last updated
- 2023-03-29
- Results posted
- 2022-04-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03411031. Inclusion in this directory is not an endorsement.