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

NCT00124813 | Unknown Phase 2

• 1 other identifier: T-CID
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Induction therapy: response rate, overall survival, death rate

• Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity

Secondary Outcomes (2)

• 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

Interventions

thalidomide DRUG

idarubicin DRUG

oral idarubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Medical Clinic & Policlinic III, University of Bonn

Bonn, 53105, Germany

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide; Idarubicin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Ingo Schmidt-Wolf, MD

  University of Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Glasmacher, MD

CONTACT

+49-228-287-15507; glasmacher@uni-bonn.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2005
• First Posted: July 28, 2005
• Study Start: August 1, 2002
• Primary Completion: May 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 2, 2010

Record last verified: 2010-02

Locations

DE (1)