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

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ClinicalTrials.gov Identifier: NCT00124813
Recruitment Status : Unknown
Verified February 2010 by University Hospital, Bonn.
Recruitment status was:  Recruiting
First Posted : July 28, 2005
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: thalidomide Drug: idarubicin Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2002
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : November 2010



Intervention Details:
    Drug: thalidomide Drug: idarubicin
    oral idarubicin


Primary Outcome Measures :
  1. Induction therapy: response rate, overall survival, death rate
  2. Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity

Secondary Outcome Measures :
  1. Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4
  2. Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124813


Contacts
Contact: Axel Glasmacher, MD +49-228-287-15507 glasmacher@uni-bonn.de

Locations
Germany
Medical Clinic & Policlinic III, 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 of Bonn

Additional Information:
Responsible Party: Prof. Dr. I. Schmidt-Wolf, University Hospital, Bonn, Germany
ClinicalTrials.gov Identifier: NCT00124813     History of Changes
Other Study ID Numbers: T-CID
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Cyclophosphamide
Thalidomide
Idarubicin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal