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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-07-31

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.

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vel/Dex

Group Type EXPERIMENTAL

bortezomib + dexamethasone

Intervention Type DRUG

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

Interventions

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bortezomib + dexamethasone

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

Intervention Type DRUG

Other Intervention Names

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VelcadeTM

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No