Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis. Induction therapy: To evaluate the efficacy and toxicity of thalidomide, cyclophosphamide, oral idarubicin and dexamethasone (T-CID) in patients with relapsed or refractory multiple myeloma. Maintenance therapy: Randomized trial to compare efficacy and toxicity of thalidomide and thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable disease after T-CID.

Detailed Description
-----------------
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis. After 3-8 cycles of T-CID patients with at least stable disease will be randomized to receive thalidomide or thalidomide plus oral idarubicin as maintenance therapy for at least one year or until progression.

Official Title
-----------------
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) as Induction Therapy and a Randomized Trial of Thalidomide vs Thalidomide Plus Oral Idarubicin as Maintenance Therapy in Patients With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: thalidomide
* Drug: idarubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multiple myeloma according to British Columbia Cancer Agency Criteria Stage IIA/B or IIIA/B according to Durie/Salmon Symptomatic or progressive disease Status of disease: refractory disease after standard induction therapy OR relapse after standard induction therapy OR relapse after high-dose chemotherapy/stem cell transplantation OR patients with plasma cell leukemia Patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration Written informed consent Exclusion Criteria: Age < 18 years Life expectancy of less than 3 months Intolerance to the study drugs No change or progressive disease after prior therapy with idarubicin or cyclophosphamide Cardiac insufficiency New York Heart Association (NYHA) grade 3 or 4 Acute infection Actually decompensated diabetes mellitus Total bilirubin > 3.0 mg/dl Pregnant or breast-feeding women Polyneuropathy grade 2 or higher Ulcus ventriculi or duodeni Narrow or open angle glaucoma Not-compensated psychiatric diseases Prior erythroblastopenia Prior therapy with investigational drugs within the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: thalidomide|nan|
|Drug: idarubicin|oral idarubicin|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction therapy: response rate, overall survival, death rate |  |  | 
| Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4 |  |  | 
| Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4 |  |  |