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Sponsored by: |
PETHEMA Foundation |
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Information provided by: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00564200 |
The primary objective of this study is to analyze the efficacy of allogeneic bone marrow transplantation in a reduced-intensity manner combined with bortezomib in the treatment of multiple myeloma with bad prognosis, in order to evaluate the response and relapse rates
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: Bortezomib Drug: dexamethasone Drug: Fludarabine Drug: Melphalan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | VELCADEXA: A Phase II National, Open-Label, Multicenter, no Controlled Study of Treated With Bortezomib (Velcade) Multiple Myeloma Patients Pre and Post Allogeneic Haematopoietic Progenitor Cell Transplant With no Myeloablative Conditioning |
Estimated Enrollment: | 30 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
PREACONDICIONAMIENTO:
ACONDICIONAMIENTO:
- Day -2: Velcade
POSTRANSPLANTATION:
PREACONDICIONAMIENTO:
- 2 cycles of 21 days : Dexamethasone: days 1-4 and 8-11
ACONDICIONAMIENTO:
- Days -9 al -5: Fludarabine
ACONDICIONAMIENTO:
- Days -4 and -3: Melphalan.
Multiple Myeloma is a plasma cell disorder characterized by an uncontrolled proliferation of bone marrow plasma cells leading to skeletal destruction with bone pain, anemia, renal failure, hypercalcemia, recurrent bacterial infections and extramedullary plasmacytomas. It accounts for 1% of all malignancies and slightly more than 10% of hematologic malignancies, with an annual incidence of about four per 100.000. Although this disease is incurable with a median survival of about 3 years, remarkable treatment advances have been recently made, including high-dose therapy followed by stem cell rescue and, particularly, the introduction of novel promising agents with new mechanisms of action.
The treatment with alquilant agents, melphalan or cyclophosphamide combined with prednisone has a median of no more than 3 years survival rate in approximately 50%. The chemotherapy combination and high-dose dexamethasone increases response rate with minimal effects in survival benefit. The limited efficacy of conventional treatment produced the introduction of the high-dose therapy followed by a stem cells transplant in order to increase antitumoral effect and prolong disease-free overall survival.
This way, autologous stem cells transplant has turned into optimal treatment for patients younger than 65 years with myeloma. Nevertheless there is increasing evidence that it benefits only patients who showed complete disease remission after transplantation.
The transcendental factor that determines the CR post-transplantation achievement is the initial chemotherapy- sensitivity disease, measuring the rapidity and the grade of response (rapidity of maximum response assessment) and the pre-transplantation M protein level (i.e., the grade of response to the initial treatment).
On the other hand, the treatments with alquilant agents can impede the obtention of adequate numbers of stem cells that make impossible the autotransplantation practice. For this reason nowadays the treatments based on dexamethasone are used as initial chemotherapy.
However, these regimens and particularly AVD have less activity than alquilant agents treatment. Bortezomib has shown a fast antimyeloma activity (response after 1 or 2 cycles) in refractory patients, where myelosuppression and cellular injury are not observed.
Alternating bortezomib and dexamethasone as pre-transplant induction regimen would show the following advantages:
Ages Eligible for Study: | 18 Years to 66 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient who displayed a Monosomy of chromosome 13 or other adverse cytogenetic abnormality.
Patient in first relapse. Patient with relapsed multiple myeloma after autologous transplantation.
Platelet count ≥ 30000/mm3 (transfusion allowed), hemoglobin ≥ 8 g/dl (transfusion allowed) and absolute neutrophil count (ANC) ≥ 0.750/mm3. Lower values are accepted if they are caused by bone marrow infiltration.
Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. Total bilirubin: ≤1.5 x the upper limit of normal. Serum creatinine value ≤ 2mg/dl
Exclusion Criteria:
Patient present serious pathologies that make impossible chemotherapy treatments:
Spain | |
H. 12 de Octubre | |
Madrid, Spain | |
H. Univ. La Princesa | |
Madrid, Spain | |
H. Univ. Gregorio Marañón | |
Madrid, Spain | |
H. Univ. de Salamanca | |
Salamanca, Spain | |
H. Clinic I Provincial | |
Barcelona, Spain | |
H. Univ. Son Dureta | |
Palma de Mallorca, Spain | |
Instituto Catalán de Oncología | |
Barcelona, Spain | |
H. de Jerez | |
Jerez de la Frontera, Spain | |
H. Univ. Morales Meseguer | |
Murcia, Spain | |
H. de la Santa Creu I Sant Pau | |
Barcelona, Spain |
Study Chair: | Bladé Joan, Dr | Hospital Clínic Barcelona |
Responsible Party: | pethema ( pethema ) |
Study ID Numbers: | 2005-004858-27 |
Study First Received: | November 26, 2007 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00564200 |
Health Authority: | Spain: Ministry of Health |
Multiple Myeloma, transplant |
Dexamethasone Melphalan Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Fludarabine monophosphate Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Fludarabine Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Cardiovascular Diseases Alkylating Agents Neoplasms by Histologic Type |
Immune System Diseases Antineoplastic Agents, Hormonal Gastrointestinal Agents Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Neoplasms Autonomic Agents Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Central Nervous System Agents |