NCT03252600

Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary Amyloidosis

A Randomized Phase 2 Trial of Lenalidomide/ Dexamethasone/ Elotuzumab +/- Cyclophosphamide Followed by Lenalidomide/ Dexamethasone/Elotuzumab Maintenance as Second-Line Therapy for Patients With Relapsed AL Amyloidosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well lenalidomide, dexamethasone, and eotuzumab with or without cyclophosphamide work in treating patients with primary amyloidosis that has come back after a period of improvement. Drugs used in chemotherapy, such as lenalidomide, dexamethasone, and cyclophosphamide, 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 eotuzumab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide, dexamethasone, and eotuzumab with cyclophosphamide may work better in treating patients with primary amyloidosis.

Detailed description

PRIMARY OBJECTIVES: I. To assess the rate of hematologic response of very good partial response (VGPR) or better according to the International Society of Amyloidosis (ISA) hematologic response criteria. SECONDARY OBJECTIVES: I. To assess duration of hematologic response. II. To assess time to hematologic progression. III. To assess overall hematologic response rate. IV. To assess complete hematologic response rate. V. To assess organ response (according to ISA organ response criteria). VI. To assess overall survival (OS). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive lenalidomide orally (PO) on days 1-21 and dexamethasone intravenously (IV) on days 1, 8, 15, and 22. Patients also receive elotuzumab IV over 1 hour on days 1, 8, 15, and 22 of courses 1 and 2 and days 1 and 15 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive lenalidomide, dexamethasone, and elotuzumab as in Arm I. Patients also receive cyclophosphamide IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: All patients receive lenalidomide PO on days 1-21 and dexamethasone IV on days 1, 8, 15, and 22. Patients also receive elotuzumab IV over 1 hour on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 24 months.

Conditions

• Recurrent Primary Amyloidosis

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given IV
DRUG	Dexamethasone	Given IV
BIOLOGICAL	Elotuzumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lenalidomide	Given PO
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2017-08-25
• Primary completion: 2023-12-07
• Completion: 2023-12-07
• First posted: 2017-08-17
• Last updated: 2023-01-25

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study