Patients with multiple myeloma earlier treated with high-dose melphalan with autologous stem cell support experiencing their first relapse.
Conditions
Interventions
Trade Name: Velcade
Product Name: Velcade
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: ·Determining the toxicity of bortezomib as part of the high-dose melphalan conditioning ·Determination of response rate of the second ASCT ·Comparison of time schedule for marrow regeneration (neutrophil- and platelet recovery) in the first and second ASCT . Comparison of the OS with the OS of matched controls from the former NMSG studies ·Subgroup analysis of patients with early relapse (within first year) vs. later relapse, different types of 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. | — |
Countries
Denmark, Sweden
Outcome results
None listed