Conditions: Primary Systemic Amyloidosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and dexamethasone together works in treating patients with primary systemic light chain amyloidosis.

Detailed description:
PRIMARY OBJECTIVE:

I. To assess the confirmed hematologic response rate of the combination of bortezomib, cyclophosphamide and dexamethasone in patients with primary systemic amyloidosis.

SECONDARY OBJECTIVES:

I. Organ response rate of the bortezomib, cyclophosphamide and dexamethasone combination.

II. Severity and frequency of adverse events associated with bortezomib, cyclophosphamide and dexamethasone treatment in patients with primary systemic amyloidosis.

III. Time to progression.

IV. Survival.

OUTLINE: Patients receive bortezomib IV on days 1, 8, and 15 and oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years.

Arms:
arm 1: Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.

Interventions: intervention 1: bortezomib intervention 2: cyclophosphamide intervention 3: dexamethasone
Intervention descriptions: intervention 1: 1.3 mg/m\^2, by IV on days 1, 8 and 15 every 28 days intervention 2: 300 mg/m\^2, orally, on days 1, 8, 15 \& 22 every 28 days. intervention 3: 40 mg, orally, on days 1, 8, 15 \& 22 every 28 days

Protocol document: