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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 Survival

Overall 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

Page last updated: August 23, 2015

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