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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University Hospital, Bonn.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00124813
First received: July 27, 2005
Last updated: February 1, 2010
Last verified: February 2010
  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
Drug: idarubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Induction therapy: response rate, overall survival, death rate [ Designated as safety issue: Yes ]
  • Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4 [ Designated as safety issue: Yes ]
  • Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4 [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2002
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: thalidomide Drug: idarubicin
    oral idarubicin
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 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
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. I. Schmidt-Wolf, University Hospital, Bonn, Germany
ClinicalTrials.gov Identifier: NCT00124813     History of Changes
Other Study ID Numbers: T-CID
Study First Received: July 27, 2005
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Cyclophosphamide
Thalidomide
Dexamethasone
Idarubicin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014