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

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
thalidomide
idarubicin
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Clinic & Policlinic III, University of BonnRecruiting

Outcomes

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

Full Information

First Posted
July 27, 2005
Last Updated
February 1, 2010
Sponsor
University Hospital, Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT00124813
Brief Title
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2002 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bonn

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
thalidomide
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Description
oral idarubicin
Primary Outcome Measure Information:
Title
Induction therapy: response rate, overall survival, death rate
Title
Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity
Secondary Outcome Measure Information:
Title
Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4
Title
Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Glasmacher, MD
Phone
+49-228-287-15507
Email
glasmacher@uni-bonn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingo Schmidt-Wolf, MD
Organizational Affiliation
University of Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Clinic & Policlinic III, University of Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingo Schmidt-Wolf, MD
Phone
+49-228-287-15507
Email
picasso@uni-bonn.de
First Name & Middle Initial & Last Name & Degree
Ingo Schmidt-Wolf, MD

12. IPD Sharing Statement

Links:
URL
http://www.myelom.net
Description
Related Info

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

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