Conditions: Leukemia Amyloidosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.

Detailed description:
The study will evaluate the 3-drug combination of lenalidomide; melphalan; and dexamethasone (MDR) as the absence of disease progression or toxicity, patients will complete nine 28-day cycles of MDR therapy, with the option of continuing treatment with lenalidomide as single-agent. Patients received up to nine cycles of treatment, with the option to continue on lenalidomide as a single agent if they responded to treatment.

Arms:
arm 1: Patients received lenalidomide 10 mg/day orally on days 1-21, melphalan 0.18 mg/kg orally on days 1-4, and dexamethasone 40 mg orally once weekly of a 28-day cycle (MDR treatment).

Interventions: intervention 1: Lenalidomide intervention 2: Melphalan intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Lenalidomide is a a derivative of thalidomide.

Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. intervention 2: Melphalan is a phenylalanine derivative of mechlorethamine.

Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle intervention 3: Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.

Orally-administered dexamethasone 40 mg orally once weekly of a 28-day cycle

Protocol document: