Clinical trial NCT02467010: Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Bortezomib
cyclophosphamide
dexamethason
multiple myeloma
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Toxicity of induction chemotherapy according to CTCAE version 3.0
timeFrame: 5 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Nij Smellinghe Hospital Drachten
name: Sjoerd Hovenga
role: PRINCIPAL_INVESTIGATOR
References: