Clinical trial NCT00124813: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2005-07-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Induction therapy: response rate, overall survival, death rate
measure: Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity
Secondary outcomes:
measure: Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4
measure: Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Medical Clinic & Policlinic III, University of Bonn
Study officials:
affiliation: University of Bonn
name: Ingo Schmidt-Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References: