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

Phase 2

• Conditions: Multiple Myeloma

• Registration Number: NCT00124813
• Lead Sponsor: University Hospital, Bonn

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.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-07-27
• Study First Submitted QC: 2005-07-27
• Study First Posted: 2005-07-28
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-02
• Primary Completion: 2010-05
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Clinic & Policlinic III, University of Bonn; 🇩🇪 Bonn, Germany