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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00124813
• Other study ID #: T-CID
• Status: Recruiting
• Phase: Phase 2
• First received: July 27, 2005
• Last updated: February 1, 2010
• Start date: August 2002
• Est. completion date: November 2010

Study information

• Verified date: February 2010
• Source: University Hospital, Bonn
• Contact: Axel Glasmacher, MD
• Phone: +49-228-287-15507
• Email: glasmacher[@]uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• thalidomide

• idarubicin
oral idarubicin

Locations

Country	Name	City	State
Germany	Medical Clinic & Policlinic III, University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction therapy: response rate, overall survival, death rate			Yes
Primary	Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity			Yes
Secondary	Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4			Yes
Secondary	Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4			Yes

External Links

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