Clinical trial · Interventional
Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance
Bortezomib in Combination With Continuous Low-dose Oral Cyclophosphamide and Dexamethason Followed by Maintenance in Primary Refractory or Relapsed Bortezomib naïve Multiple Myeloma Patients. A Prospective Phase II Study.
- 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)
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.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib, cyclophosphamide, dexamethason
- description
- * 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.
- interventionNames
- Drug: Bortezomib
- Drug: Cyclophosphamide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Toxicity of induction chemotherapy according to CTCAE version 3.0
- timeFrame
- 5 years
Secondary outcomes (2)
- measure
- Progression Free Survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available