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

University Hospital Bonn (UKB)

Status and phase: Unknown; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: thalidomide; Drug: idarubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00124813

T-CID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)