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| Sponsors and Collaborators: |
TampereUH Turku University Hospital Oulu University Hospital Kuopio University Hospital Janssen-Cilag Ltd. |
|---|---|
| Information provided by: | TampereUH |
| ClinicalTrials.gov Identifier: | NCT00861250 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma Bortezomib Plus Dexamethasone Induction Therapy Autologous Stem Cell Transplantation Molecular Remission |
Drug: bortezomib + dexamethasone |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Assessment of Molecular Remission by ASO-RQ-PCR Technique After Induction Treatment With Bortezomib-Dexamethasone (Vel/Dex) Followed by HDT With ASCT |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Vel/Dex: Experimental |
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Raija H Silvennoinen, MD | +358 3 311 67558 | raija.silvennoinen@pshp.fi |
| Contact: Maija A Itälä, MD,PhD | +358 3 311 67868 | maija.itala@pshp.fi |
| Finland, Pirkanmaa | |
| Tampere University Hospital | Recruiting |
| Tampere, Pirkanmaa, Finland, 33 521 | |
| Principal Investigator: Raija H Silvennoinen, MD | |
| Principal Investigator: | Raija H Silvennoinen, MD | TampereUH |
More Information
| Responsible Party: | Tampere University Hospital ( Raija Silvennoinen ) |
| Study ID Numbers: | R08096M, VEL-1-08-DK-002, 26866138MMY2063 |
| Study First Received: | March 12, 2009 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00861250 History of Changes |
| Health Authority: | Finland: National Agency for Medicines |
|
Anti-Inflammatory Agents Dexamethasone Immunoproliferative Disorders Antineoplastic Agents, Hormonal Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Bortezomib Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases Antiemetics |
Paraproteinemias Hemostatic Disorders Hormones Glucocorticoids Protease Inhibitors Multiple Myeloma Hemorrhagic Disorders Peripheral Nervous System Agents Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
|
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Dexamethasone acetate |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Vascular Diseases Gastrointestinal Agents Enzyme Inhibitors Glucocorticoids Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Autonomic Agents |
