Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT02467010
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated high response rates in refractory multiple myeloma. Low dose continuous cyclophosphamide, also called metronomic scheduling, minimize toxic side effects and eliminate the obligatory rest periods. Combining cyclophosphamide with bortezomib might target distinct aspects of a myeloma functionality.
The objectives of the present study are whether patients with refractory or relapsed multiple myeloma after reinduction with bortezomib, cyclophosphamide and dexamethasone will benefit from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects. Recently two studies have shown with thalidomide that maintenance therapy might improve EFS and one study also the OS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- Age ≥ 18 years
- Stage II-III Multiple Myeloma
- Relapse or primary refractory disease after initial chemotherapy
- WHO performance status 0 - 2
- Life expectancy of at least 6 weeks
- ANC (absolute neutrophil count) ≥ 1.0x109/l(or ≥ 0.5x109/l, if due to bone marrow infiltration by malignancy)
- Platelet count ≥ 75x109/l or ≥ 50x109/l, if due to bone marrow infiltration by malignancy)
- Written informed consent (present in patient's file)
- Patient is able and willing to use adequate contraception during therapy and for at least 1 month after study
- Patient has the ability to understand the requirements of the study
- Previous treatment with bortezomib
- Urine production < 1.5 l/24h
- Pre-existent polyneuropathy (grade 2 or higher, according to CTCAE 3.0)
- Pregnancy or positive pregnancy tests during study and for 1 month after final dose of thalidomide
- History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin)
- Active uncontrolled infections
- Additional uncontrolled serious medical or psychiatric illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bortezomib, cyclophosphamide, dexamethason Bortezomib * To assess the efficacy of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy. * To assess the safety of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy in patients with refractory or relapsed multiple myeloma. Bortezomib, cyclophosphamide, dexamethason Cyclophosphamide * To assess the efficacy of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy. * To assess the safety of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy in patients with refractory or relapsed multiple myeloma. Bortezomib, cyclophosphamide, dexamethason Dexamethasone * To assess the efficacy of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy. * To assess the safety of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy in patients with refractory or relapsed multiple myeloma.
- Primary Outcome Measures
Name Time Method Toxicity of induction chemotherapy according to CTCAE version 3.0 5 years
- Secondary Outcome Measures
Name Time Method Overall Survival 5 years Progression Free Survival 5 years
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands