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
Recruitment status was Recruiting
Sponsor:
University Hospital, Bonn
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00124813
First received: July 27, 2005
Last updated: February 1, 2010
Last verified: February 2010
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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:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Dexamethasone
Cyclophosphamide
Thalidomide
Dexamethasone acetate
Dexamethasone sodium phosphate
Idarubicin hydrochloride
Idarubicin
U.S. FDA Resources
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:
Detailed Description:
-
Drug: thalidomide
Drug: idarubicin
oral idarubicin
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 Hospital, 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 May 22, 2013