Conditions: Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant.

Detailed description:
Multiple myeloma (MM) is an incurable hematological malignancy of plasma cell origin. Plasma cell clonality and dysfunctional immunoglobulin production characterize the disease. The consequences of abnormal plasma cell growth are manifested by a myriad of symptoms and signs that often have significant impact on the patient's quality of life. These include pancytopenia secondary to predominant distribution of tumor cells within the bone marrow along with many other effects.

This study is focused on the efficacy of Doxil® (pegylated liposomal doxorubicin) with low dose Dexamethasone and Thalidomide (Ddt) in previously untreated patients with multiple myeloma.

Arms:
arm 1: Doxil, Thalidomide, Dexamethasone

Interventions: intervention 1: Doxil intervention 2: Thalidomide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Doxil 40 mg/m2 IV day 1 intervention 2: 50-100 mg day 1-28 intervention 3: Dexamethasone 40 mg day 1-4 and 15-18

Protocol document: