Status:
COMPLETED
Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed by ASCT
Lead Sponsor:
Tampere University Hospital
Collaborating Sponsors:
Turku University Hospital
Oulu University Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- Symptomatic multiple myeloma
- Age 18-65 years
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00861250
Start Date
March 1 2009
End Date
July 1 2015
Last Update
June 17 2016
Active Locations (1)
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1
Tampere University Hospital
Tampere, Pirkanmaa, Finland, 33 521