MINIALO-VELCADE2005: A Study of Bortezomib (Velcade) Treated Multiple Myeloma Patients Pre and Post Allogeneic Haematopoietic Progenitor Cell Transplant With no Myeloablative Conditioning

NCT00564200 | Completed Phase 2 DMC

• 1 other identifier: 2005-004858-27
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, transplant

Outcome Measures

Primary Outcomes (1)

• Analyze the efficacy of allogeneic bone marrow transplantation in a reduced-intensity manner combined with bortezomib

  2 years

Interventions

Bortezomib DRUG

PREACONDICIONAMIENTO: * 2 cycles of 21 days : Velcade days: 1, 4, 8 and 11 * 1 cycle of 13 days : Velcade days 1, 4, 8 and 11 ACONDICIONAMIENTO: \- Day -2: Velcade POSTRANSPLANTATION: * 2 cycles of 21 days : Velcade days 1, 8 and 15 * 5 cycles of 56 days : Velcade days 1, 8 and 15

dexamethasone DRUG

PREACONDICIONAMIENTO: \- 2 cycles of 21 days : Dexamethasone: days 1-4 and 8-11

Fludarabine DRUG

ACONDICIONAMIENTO: \- Days -9 al -5: Fludarabine

Melphalan DRUG

ACONDICIONAMIENTO: \- Days -4 and -3: Melphalan.

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
• Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• Age over 18 and under 67 years old.
• Patient diagnosed with symptomatic Multiple Myeloma based on standard criteria with bad prognosis. This factor is associated with at least one of the clinical alterations defined as follows:
• 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.
• Patient has a ECOG performance status \<= 2.
• Patient has a life-expectancy \>3 months.
• Patients who are candidates for autologous transplantation.
• Patients must have HLA-identical sibling donors.
• Patient has the following laboratory values before Baseline visit:
• 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

You may not qualify if:

• Patient present serious pathologies that make impossible chemotherapy treatments:
• Congestive heart failure, angina or heart attack during last 12 months.
• Uncontrolled arterial hypertension.
• Uncontrolled supraventricular arrhythmias during last 3 last months.
• Ventricular arrhythmia.
• Hepatic disease (Cirrhosis).
• Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.
• Patient with serious psychiatric disorders that make impossible comply satisfactorily with the protocol requirements.
• Personal medical history of neoplasia of other type, except: carcinoma in situ, other curatively treated malignancy in complete remission for more than 10 years.
• Patient has hypersensitivity to bortezomib, boron or mannitol.
• Fertile patient is not going to use a medical effective contraceptive method during the trial.
• Patient has received other investigational drugs within 30 days before enrollment
• Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection.
• Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (10)

H. Clinic I Provincial

Barcelona, Spain

Location

H. de la Santa Creu I Sant Pau

Barcelona, Spain

Location

Instituto Catalán de Oncología

Barcelona, Spain

Location

H. de Jerez

Jerez de la Frontera, Spain

Location

H. 12 de Octubre

Madrid, Spain

Location

H. Univ. Gregorio Marañón

Madrid, Spain

Location

H. Univ. La Princesa

Madrid, Spain

Location

H. Univ. Morales Meseguer

Murcia, Spain

Location

H. Univ. Son Dureta

Palma de Mallorca, Spain

Location

H. Univ. de Salamanca

Salamanca, Spain

Location

Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Dexamethasone; fludarabine; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Bladé Joan, Dr

  Hospital Clinic of Barcelona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 27, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

ES (10)