Trials / Terminated
TerminatedNCT03333746
Lenalidomide and Nivolumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
Phase II Study of Lenalidomide in Combination With Nivolumab In Patients With Relapsed/Refractory Multiple Myeloma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Yvonne Efebera · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well lenalidomide and nivolumab work in treating patients with multiple myeloma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and nivolumab may work better in treating patients with multiple myeloma.
Detailed description
PRIMARY OBJECTIVES: I. To determine the efficacy of nivolumab in combination with lenalidomide (Revlimid) in terms of overall response rate in patients with relapse/refractory multiple myeloma (MM). OUTLINE: Patients receive lenalidomide orally (PO) on days 1-21 and nivolumab intravenously (IV) over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| DRUG | Lenalidomide | Given PO |
| BIOLOGICAL | Nivolumab | Given IV |
| OTHER | Pharmacological Study | Correlative studies |
Timeline
- Start date
- 2018-03-21
- Primary completion
- 2018-08-13
- Completion
- 2018-11-16
- First posted
- 2017-11-07
- Last updated
- 2019-05-30
- Results posted
- 2019-05-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03333746. Inclusion in this directory is not an endorsement.