Phase II study of bortezomib-dexametason and high-dose melphalan in patients relapsing after high-dose melphalan with autologous stem cell support

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

·First relapse after ASCT
·Symptomatic myeloma diagnosis according to international criteria
·More than 2,0 x 106 CD34+ stem cells / kg bodyweight in the freezer for
stem cell support
·Signed informed consent given prior to any study related activities have
been performed
·Age > 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Allogeneic transplantation scheduled as a part of the treatment
·Expected survival of less than one month.
·Performance status (WHO) > 3
·Neuropathy > Grade 2(neurological symptoms interfering with ADL)
·Non-secreting myeloma
·Other concurrent disease making bortezomib treatment unsuitable
·Positive pregnancy test (only applicable for women with childbearing
potential)
·Has known or suspected hypersensitivity or intolerance to boron,
mannitol, or heparin, if an indwelling catheter is used
·Uncontrolled or severe cardiovascular disease including myocardial
infarction within 6 months of enrolment, New York Heart Association
(NYHA) Class III or IV heart failure (NYHA Classification of Cardiac
Disease), uncontrolled angina, clinically significant pericardial disease, or
cardiac amyloidosis
·History of hypotension or has decreased blood pressure (sitting systolic
blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure
[DBP] £60 mmHg)
·Serious medical or psychiatric illness likely to interfere with participation in
this clinical study
·Have received an experimental drug or used an experimental medical
device within 4 weeks prior to inclusion into the study
. Earlier treatment with bortezomid

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ·Determining the toxicity of bortezomib as part of the high-dose melphalan conditioning <br>·Determination of response rate of the second ASCT<br>·Comparison of time schedule for marrow regeneration (neutrophil- and <br> platelet recovery) in the first and second ASCT<br>. Comparison of the OS with the OS of matched controls from the former <br> NMSG studies<br>·Subgroup analysis of patients with early relapse (within first year) vs. later <br> relapse, different types of relapse<br>;Main Objective: Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse.;Primary end point(s): Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse.<br>

Secondary Outcome Measures

Name	Time	Method

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