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

Tampere University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: bortezomib + dexamethasone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00861250

26866138MMY2063 (Other Grant/Funding Number)

R08096M

2008-003936-38 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Vel/Dex

Experimental group

Treatment:

Drug: bortezomib + dexamethasone