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

June 15, 2016 updated by: Tampere University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33 521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vel/Dex
Drug: 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
Other Names:
  • VelcadeTM

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Turku University Hospital
Helsinki University Central Hospital
Oulu University Hospital
Kuopio University Hospital
Seinajoki Central Hospital
Janssen-Cilag Ltd.
Päijänne Tavastia Central Hospital
Jyväskylä Central Hospital
Kanta-Häme Central Hospital

Investigators

  • Principal Investigator: Raija H Silvennoinen, MD, Tampere University Hospital, Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimate)

March 13, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R08096M
  • 2008-003936-38 (EudraCT Number)
  • 26866138MMY2063 (Other Grant/Funding Number: Janssen-Cilag Ltd)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Clinical Study Report
    Information comments: First study article: http://www.ncbi.nlm.nih.gov/pubmed/23206270

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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