Clinical trial NCT00861250: Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed by ASCT
Official title: Assessment of Molecular Remission by ASO-RQ-PCR Technique After Induction Treatment With Bortezomib-dexamethasone (Vel/Dex) Followed by HDT With ASCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Myeloma
Keywords: Bortezomib plus dexamethasone induction therapy
Autologous stem cell transplantation
Molecular remission
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Oulu University Hospital
name: Kuopio University Hospital
name: Helsinki University Central Hospital
name: Kanta-Häme Central Hospital
name: Seinajoki Central Hospital
name: Jyväskylä Central Hospital
name: Janssen-Cilag Ltd.
name: Päijänne Tavastia Central Hospital
First posted: 2009-03-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR
timeFrame: Before ASCT and 3-4 months after ASCT and then with 3-4 months interval
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
affiliation: Tampere University Hospital, Kuopio University Hospital
name: Raija H Silvennoinen, MD
role: PRINCIPAL_INVESTIGATOR
References: