Clinical trial NCT00833560: A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy
Official title: Clinical Study on Induction of Remission Using Bortezomib (Vel), Cyclophosphamide (C), and Dexamethasone (D) in Patients Until 60 Years of Age With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy: (VelCD; Deutsche Studiengruppe Multiples Myelom [DSMM] XIa)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Untreated multiple myeloma
Bortezomib
VELCADE
Cyclophosphamide
Dexamethasone
Chemotherapy
Remission therapy
Induction therapy
Stem Cell Transplantation
Lead sponsor: Janssen-Cilag G.m.b.H
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone.

Detailed description: This is open-label (both the participant and the investigator know what treatment participants will receive), prospective (participants are identified and then followed forward in time for the outcome of the study), multi-centre, and non-randomized (participants are assigned to different treatment groups by the investigator) study. The study will be conducted into 2 parts (Part 1 and Part 2). Approximately 400 participants will be enrolled (30 in Part 1 and 370 in Part 2). In Part 1 the optimum dose of cyclophosphamide will be evaluated and in Part 2 the selected dose of cyclophosphamide from Part 1 will be administered. Part 2 will include a screening period of a maximum of 14 days followed by chemotherapy (bortezomib, cyclophosphamide, and dexamethasone) of a maximum of three 21-day cycles. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, electrocardiogram, and clinical laboratory tests which will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Cytologically or histologically diagnosed with multiple myeloma stage II/III
* Participants without preceding cytostatic (tending to retard cellular activity and multiplication) treatment (pretreatment with radiation or dexamethasone is allowed)
* Agree to use one of the contraception methods as defined in the protocol
* Karnofsky performance status 60 percent or more
* Adequate laboratory test values

Exclusion Criteria:

* Non-secretory multiple myeloma
* Estimated life expectancy less than 3 months
* History of cancer (except basal cell carcinoma) in the last 5 years
* Peripheral neuropathy (disorder of the peripheral nerves) grade 2 or more
* Positive human immunodeficiency virus test and active hepatitis B and/or hepatitis C
* Pregnant or breast-feeding female participants

Primary outcomes:
measure: Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)
timeFrame: Up to Day 63
Secondary outcomes:
measure: Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)
timeFrame: Up to Day 63
measure: Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)
timeFrame: Up to Day 63
measure: Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)
timeFrame: Up to Day 63
Other outcomes:
Locations:
city: Berg
country: Germany
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Dresden
country: Germany
city: Erlangen
country: Germany
city: Frankfurt / Main
country: Germany
city: Freiburg
country: Germany
city: Greifswald
country: Germany
city: Göttingen
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Hamm
country: Germany
city: Hannover
country: Germany
city: Homburg
country: Germany
city: Jena
country: Germany
city: Karlsruhe
country: Germany
city: Kiel
country: Germany
city: Lübeck
country: Germany
city: Magdeburg
country: Germany
city: Mainz
country: Germany
city: Muenchen
country: Germany
city: Mutlangen
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Nürnberg
country: Germany
city: Oldenburg
country: Germany
city: Potsdam
country: Germany
city: Regensburg
country: Germany
city: Rehling
country: Germany
city: Rostock
country: Germany
city: Stuttgart
country: Germany
city: Tübingen
country: Germany
city: Ulm
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Würzburg
country: Germany
Study officials:
affiliation: Janssen-Cilag G.m.b.H
name: Janssen-Cilag G.m.b.H, Germany Clinical Trial
role: STUDY_DIRECTOR
References: