MedTrace Logo

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

NCT00861250 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2016-06-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Turku University Hospital

    collaborator OTHER_GOV

  • Oulu University Hospital

    collaborator OTHER

  • Kuopio University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Kanta-Häme Central Hospital

    collaborator OTHER_GOV

  • Seinajoki Central Hospital

    collaborator OTHER

  • Jyväskylä Central Hospital

    collaborator OTHER

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • Päijänne Tavastia Central Hospital

    collaborator OTHER

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Raija H Silvennoinen, MD · Tampere University Hospital, Kuopio University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-12-31
Completion
2015-07-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861250 on ClinicalTrials.gov