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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tampere University Hospital
• Collaborators: Central Hospital of Kanta-Hame; Helsinki University Central Hospital; Janssen-Cilag Ltd.; Jyväskylä Central Hospital; Kanta-Häme Central Hospital; Kuopio University Hospital; Oulu University Hospital; Päijänne Tavastia Central Hospital; Seinajoki Central Hospital; Turku University Hospital
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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