Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance
Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Bortezomib (Drug); Cyclophosphamide (Drug); Dexamethasone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Medical Center Groningen Official(s) and/or principal investigator(s): Sjoerd Hovenga, Principal Investigator, Affiliation: Nij Smellinghe Hospital Drachten
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.
Clinical Details
Official title: 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.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Toxicity of induction chemotherapy according to CTCAE version 3.0
Secondary outcome: Progression Free SurvivalOverall Survival
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Medical Center Groningen, Groningen 9713 GZ, Netherlands
Additional Information
Starting date: September 2008
Last updated: June 8, 2015
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