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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00124813
• Date of registration: 27/07/2005
• Primary sponsor: University Hospital, Bonn
• Public title: Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma
• Scientific 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
• Date of first enrolment: August 2002
• Target sample size: 80
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00124813
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Ingo Schmidt-Wolf, MD

• Name: Axel Glasmacher, MD

• Name: Ingo Schmidt-Wolf, MD
• Affiliation: University Hospital, Bonn

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: idarubicin

Drug: thalidomide

Primary Outcome(s)

Induction therapy: response rate, overall survival, death rate [Time Frame: Yes]

Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity [Time Frame: Yes]

Secondary Outcome(s)

Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4 [Time Frame: Yes]

Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4 [Time Frame: Yes]

Secondary ID(s)

T-CID

Source(s) of Monetary Support

Please refer to primary and secondary sponsors