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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861250
• Other study ID #: R08096M
• Secondary ID: 2008-003936-3826
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 12, 2009
• Last updated: June 15, 2016
• Start date: March 2009
• Est. completion date: July 2015

Study information

• Verified date: December 2014
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere	Pirkanmaa

Sponsors (10)

Lead Sponsor	Collaborator
Tampere University Hospital	Central Hospital of Kanta-Hame, Helsinki University Central Hospital, Janssen-Cilag Ltd., Jyväskylä Central Hospital, Kuopio University Hospital, Oulu University Hospital, Päijänne Tavastia Central Hospital, Seinajoki Central Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR		Before ASCT and 3-4 months after ASCT and then with 3-4 months interval	No