VELCADEXA: Velcade and Dexamethasone in Multiple Myeloma

NCT00391157 | Completed Phase 2

• 2 other identifiers: 2005-000186-19VELCADEXA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 10

Brief Summary

The primary efficacy objective of this study is to study the efficacy in terms of response rate to alternating bortezomib/dexamethasone regimen

Conditions

Multiple Myeloma

Keywords

Múltiple Myeloma; Transplant; Patients <65 years.

Outcome Measures

Primary Outcomes (1)

• Response rate

  6 months

Secondary Outcomes (3)

• Compare the efficacy of velcade and dexamethasone with chemotherapy combination VBMCP/VBAD

  1 year

• Evaluate the quality of progenitors cells after treatment with Velcade and dexamethasone

  6 months

• Compare the complete response rate after high dose therapy in patients treated with velcade and dexamethasone or VBMCP/VBAD

  6 months

Interventions

Velcade/Dexamethasone DRUG

Velcade 1,3 mg/m2 on days 1, 4, 8 and 11

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 65 years old.
• Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria and that has not received any previous chemotherapy treatment for Multiple Myeloma.
• Patient has measurable disease, defined as follows:
• For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours.
• For poor or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligosecretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine by immunofixation.
• Patient has a ECOG performance status \< 2.
• Patient has a life-expectancy \>3 months.
• Patient has the following laboratory values within 14 days before Baseline visit (Day 1 of Cycle 1, before study drug administration):
• Platelet count ≥ 50x109/L, hemoglobin ≥ 8 g/dl and absolute neutrophil count (ANC) ≥ 1.0x109/L; Corrected serum calcium \<14mg/dl. 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 previously received treatment with VELCADE.
• Patient previously received treatment for Multiple Myeloma
• Patient had major surgery within 4 weeks before enrollment.
• Patient has a platelet count \< 50x 109/L within 14 days before enrollment.
• Patient has an absolute neutrophil count \< 1.0 x 109/L within 14 days before enrollment.
• Patient has \< Grade 2 peripheral neuropathy within 14 days before enrollment.
• Patient has hypersensitivity to bortezomib, boron or mannitol.
• Patient has received other investigational drugs within 14 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.
• Pregnancy, breast-feeding or fertile women who are not going to use a medical effective contraceptive method during the trial.

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (10)

Hospital Clínic

Barcelona, Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Barcelona, Spain

Location

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

Location

Hospital Doce de Octubre

Madrid, Madrid, Spain

Location

Hospital Universitario de la Princesa

Madrid, Madrid, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital General de Segovia

Segovia, Spain

Location

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Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Dexamethasone

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

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

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 23, 2006
• Study Start: August 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: January 1, 2008
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

ES (10)