Clinical trial · Interventional
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| idarubicin | Drug | Idarubicin | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- 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 (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available