Trial document

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This study has been imported from ClinicalTrials.gov without additional data checks.

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DRKS-ID: DRKS00003762

Trial Description

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Title

Phase II/III Study for Remission Induction With Bortezomib (Vel), Cyclophosphamide (C) and Dexamethasone (D) in Patients <= 60 Years With Untreated Multiple Myeloma and Planned High Dose Chemotherapy: (VelCD)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this clinical study is to investigate induction therapy for remission with
bortezomib, cyclophosphamide and dexamethasone in patients aged 60 years and younger with
multiple myeloma planned for high-dose chemotherapy with stem cell transplantation.

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Brief Summary in Scientific Language

Today high dose chemotherapy (HD-CT) with stem cell support is considered the standard for
younger patients with multiple myeloma. The standard protocol for induction therapy before
HD-CT is a combination therapy consisting of vincristine, adriamycin and dexamethasone. 40%
of the patients do not respond to conventional induction therapy. With the combination of
bortezomib and cyclophosphamide, a potent cytotoxic substance already in use against
multiple myeloma, an increased efficacy is expected. In this prospective, open-label,
single arm, multi-center study, induction therapy for remission with bortezomib,
cyclophosphamide and dexamethasone in patients aged 60 years and younger with multiple
myeloma planned for high-dose chemotherapy with stem cell transplantation is investigated.
In the first part an evaluation of an optimal dose of cyclophosphamide if combined with a
fixed bortezomib and dexamethasone dose is done and in the second part, efficacy and
tolerance of the assessed dose is evaluated. Primary outcome of the second part is response
prior to high dose chemotherapy. The first part (dose definition) has already been
completed.On the days patients receive bortezomib, vital signs and blood tests and, at the
first day of each cycle, a physical examination will be performed. Adverse events are to be
documented and reported during the study in accordance with ICH-GCP guidelines. 400 male and
female patients with untreated Multiple Myeloma are to be included in this study. In the
first part of the study, the number of patients was restricted to 30. Thus, approximately
370 patients were to be included in the second part. Bortezomib 1,3 mg/m2 by intravenous
bolus on Day 1, 4, 8, and 11 for a maximum of 3 cycles. One cycle consists of 21 days.
Cyclophosphamide 900mg as intravenous infusion on Day 1 of each cycle. Dexamethasone 40 mg
on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle.

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Organizational Data

DRKS-ID: DRKS00003762
Date of Registration in DRKS: 2012/05/02
Date of Registration in Partner Registry or other Primary Registry: 2009/01/23
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee No.: [---]*

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Secondary IDs

Primary Registry-ID: NCT00833560 (ClinicalTrials.gov)
Sponsor-ID: CR005242 (Janssen-Cilag G.m.b.H)

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Health Condition or Problem studied

Free text: Multiple Myeloma
Free text: Remission Induction
Free text: Stem Cell Transplantation
ICD10: C90.0 - Multiple myeloma

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Interventions/Observational Groups

Arm 1: Drug: Cyclophosphamide (Cy)
Arm 2: Drug: Bortezomib (Btz)
Arm 3: Drug: Dexamethasone (D)

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Treatment
Assignment: Single (group)
Phase: II-III
Off-label Drug use: [---]*

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Primary Outcome

- Efficacy (Response); time frame: efficacy of response after every one of three cycles

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Secondary Outcome

- Tolerability and comparison of response rates in different cytogenetic risk groups; time frame: efficacy of response after every one of three cycles

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Countries of Recruitment

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Locations of Recruitment

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Recruitment

Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2006/03/31
Target Sample Size: 401
Monocenter/Multicenter trial: [---]*
National/International: [---]*

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 60 Years

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Additional Inclusion Criteria

- Multiple Myeloma stage II/III Durie and Salmon

- Patients without preceding cytostatic treatment, however, pretreatment with
dexamethasone is allowed

- Written informed consent

- Female patients have to be postmenopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e.1 hormonal contraceptives, intrauterine
device, diaphragm with spermicide, total abstinence or a vasectomised partner) during
and 6 months after the treatment, pregnancy test has to be negative

- Male patients have to use an acceptable method of birth control during and 6 months
after the treatment

- males should be offered sperm cryoconservation

- Karnofsky performance status >= 60%

- AST and ALT < 2.5 x the upper limit of normal (ULN)

- Bilirubin < 2.5 x the upper limit of normal (ULN)

- Adequate haematological parameters: leucocytes >= 3.0 x 109/l, neutrophils >= 1.5 x
109/l, platelets >= 75 x 109/l

- Creatinin < 2 x the upper limit of normal (ULN)

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Exclusion Criteria

- Non-secretory multiple myeloma

- known allergy or hypersensitivity to bortezomib, bor, mannitol, cyclophosphamide

- Estimated life expectancy less than 3 months

- History of cancer (except basal cell carcinoma) in the last 5 years

- Patients with history of peripheral neuropathy CTC grade >= 2

- Other severe illnesses that could potentially interfere with the completion of
treatment according to this protocol: a. Insufficient liver or renal function,
clinically relevant lung disease or gastrointestinal diseases, b. New York Heart
Association (NYHA) > Class II heart failure, myocardial infarction within 6 months of
enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias (Lown
IVB), electrocardiographic evidence of acute ischemia or active conduction system
abnormalities, cardiac amyloidosis, c. Active systemic infection requiring treatment,
d. Poorly controlled hypertension or vascular disease. Diabetes mellitus, or other
serious endocrine or metabolic diseases

- Patients with hypotension (defined as RRsys sitting <= 100 mmHg and/or RRdia sitting
<= 60 mmHg

- HIV positive patients

- Patients with active hepatitis B and/or C

- Pregnant or breast-feeding female patients

- Insufficient compliance, foreseeable follow-up problems, psychiatric diseases, known
abuse of alcohol or drugs, legal incompetence

- Participation in another trial either parallel to this trial or within the last 30
days before enrollment into this trial

- except drug studies for relapse in the observation period.

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Addresses

Primary Sponsor
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- Janssen-Cilag G.m.b.H
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Janssen-Cilag G.m.b.H
- Janssen-Cilag G.m.b.H. Clinical Trial
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Public Queries
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- Janssen-Cilag G.m.b.H
- Janssen-Cilag G.m.b.H. Clinical Trial
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Sources of Monetary or Material Support

[---]*
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2009/06/01

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Trial Publications, Results and other Documents

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Translation on version: 45
Last processed date by ClinicalTrials.gov: 2013/10/30

* This entry means the parameter is not applicable or has not been set.