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

Sponsored by:	University Hospital, Bonn
Information provided by:	University Hospital, Bonn
ClinicalTrials.gov Identifier:	NCT00124813

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: thalidomide	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Cyclophosphamide Idarubicin Idarubicin hydrochloride Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Thalidomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	80
Study Start Date:	August 2002
Estimated Study Completion Date:	March 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124813

Contacts

Contact: Axel Glasmacher, MD

+49-228-287-15507

glasmacher@uni-bonn.de

Locations

Germany
Medical Clinic & Policlinic I, University of Bonn	Recruiting
Bonn, Germany, 53105
Contact: Ingo Schmidt-Wolf, MD +49-228-287-15507 picasso@uni-bonn.de
Principal Investigator: Ingo Schmidt-Wolf, MD

Sponsors and Collaborators

University Hospital, Bonn

Investigators

Principal Investigator:

Ingo Schmidt-Wolf, MD

University Hospital, Bonn

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	T-CID
Study First Received:	July 27, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00124813
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Cyclophosphamide

Hemostatic Disorders
Multiple Myeloma
Idarubicin
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Antibiotics, Antineoplastic
Hormones
Anti-Bacterial Agents
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents

Alkylating Agents
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Growth Substances
Gastrointestinal Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009