Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed by ASCT

Study Overview
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Brief Summary
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The primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.

Detailed Description
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HDT-ASCT is so far considered the standard of care for younger patients with multiple myeloma (MM). Current evidence indicates that quality of response is an important prognostic factor for long-term survival in MM. There are only very few data on molecular remissions (MolR) determined by the most sensitive technique, allele-specific-oligonucleotide - real-time quantitative - polymerase chain reaction (ASO-RQ-PCR) in MM, and there are no data available on molecular responses after bortezomib-based induction therapy followed by HDT-ASCT. The main aim of this study is to determine molecular response rate after ASCT following bortezomib-based induction treatment compared to a historical control group with conventional VAD induction treatment. A sensitivity of ASO-RQ-PCR technique will be compared to immunofixation and with immunophenotyping by flow cytometry.

Official Title
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Assessment of Molecular Remission by ASO-RQ-PCR Technique After Induction Treatment With Bortezomib-dexamethasone (Vel/Dex) Followed by HDT With ASCT

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: bortezomib + dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic multiple myeloma Age 18-65 years Written informed consent Exclusion Criteria: WHO performance status ≥ 2, unless related to MM Severe cardiac dysfunction History of hypotension Serious medical or psychiatric illness Severe hepatic dysfunction Severe polyneuropathy ≥ grade 2 Active, uncontrolled infection Previously treated with chemotherapy or extensive radiotherapy for MM Known HIV positivity Severe renal dysfunction with need of dialyses History of active cancer during past 5 years, except non-melanoma skin cancer or stage 0 cervical cancer Female patients who are pregnant or nursing Male or female patients of reproductive potential who are not practising effective means of contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vel/Dex<br> | Drug: bortezomib + dexamethasone<br>* Bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4, 9-12 in cycles 1- 2, then bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4 in cycles 3-4, total number of cycles is 4, followed by HDT with ASCT<br>* Other names: VelcadeTM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR |  | Before ASCT and 3-4 months after ASCT and then with 3-4 months interval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bortezomib plus dexamethasone induction therapy, Autologous stem cell transplantation, Molecular remission