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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

Phase 2/Phase 3
18 Years
65 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR

Outcome Time Frame:

Before ASCT and 3-4 months after ASCT and then with 3-4 months interval

Safety Issue:


Principal Investigator

Raija H Silvennoinen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tampere University Hospital, Kuopio University Hospital


Finland: Finnish Medicines Agency

Study ID:




Start Date:

March 2009

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • Bortezomib plus dexamethasone induction therapy
  • Autologous stem cell transplantation
  • Molecular remission
  • Multiple Myeloma
  • Neoplasms, Plasma Cell