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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Medical Clinic & Policlinic III, University of Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Ingo Schmidt-Wolf, MD University of Bonn
  More Information

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 
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
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
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

ClinicalTrials.gov processed this record on December 09, 2016