search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
bortezomib + dexamethasone
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Bortezomib plus dexamethasone induction therapy, Autologous stem cell transplantation, Molecular remission

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vel/Dex

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 12, 2009
Last Updated
June 15, 2016
Sponsor
Tampere University Hospital
Collaborators
Turku University Hospital, Oulu University Hospital, Kuopio University Hospital, Helsinki University Central Hospital, Kanta-Häme Central Hospital, Seinajoki Central Hospital, Jyväskylä Central Hospital, Janssen-Cilag Ltd., Päijänne Tavastia Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00861250
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
Collaborators
Turku University Hospital, Oulu University Hospital, Kuopio University Hospital, Helsinki University Central Hospital, Kanta-Häme Central Hospital, Seinajoki Central Hospital, Jyväskylä Central Hospital, Janssen-Cilag Ltd., Päijänne Tavastia Central Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Bortezomib plus dexamethasone induction therapy, Autologous stem cell transplantation, Molecular remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vel/Dex
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bortezomib + dexamethasone
Other Intervention Name(s)
VelcadeTM
Intervention Description
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
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raija H Silvennoinen, MD
Organizational Affiliation
Tampere University Hospital, Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33 521
Country
Finland

12. IPD Sharing Statement

Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/25303369
Available IPD/Information Comments
First study article: http://www.ncbi.nlm.nih.gov/pubmed/23206270

Learn more about this trial

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

We'll reach out to this number within 24 hrs