Velcade/Dexamethasone in Multiple Myeloma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Multiple Myeloma

Intervention / Treatment

Drug: Velcade/Dexamethasone

Detailed Description

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.

Data from pre-clinical and clinical studies conducted to date support the continued development of VELCADE for the treatment of Multiple Myeloma. Standard chemotherapy remains as the gold standard for induction before HDT/SCT treatment in younger multiple myeloma patients (<65 years). Since VELCADE has a mechanism of action different from chemotherapy and dexamethasone and is considered to be efficacious in Multiple Myeloma, its introduction in induction regimens may contribute to increase the response rate and eventually survival of these patients that represent half of myeloma population.

Since VBMCP/VBAD is considered to be the gold standard for Multiple Myeloma patients <65 years as induction regimen prior HDT/SCT, the results of VEL/DEX will be compared with those obtained in 100 patients treated with VBMCP/VBAD chemotherapy in our last GEM protocol (Spanish Myeloma Group) for patients <65 years (closed in Dec 2004

Study Type

Interventional

Enrollment (Actual)

40

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Barcelona, Spain
    - Hospital de La Santa Creu i Sant Pau
  - Barcelona, Spain
    - Hospital Clinic
  - Barcelona, Spain
    - Hospital Germans Trías i Pujol
  - Madrid, Spain
    - Hospital Clínico San Carlos de Madrid
  - Madrid, Spain
    - Hospital Doce de Octubre
  - Madrid, Spain
    - Hospital Universitario de La Princesa
  - Salamanca, Spain
    - Hospital Universitario De Salamanca
  - Segovia, Spain
    - Hospital General de Segovia
  - Valencia, Spain
    - Hospital La Fe
- Navarra
  - Pamplona, Navarra, Spain
    - Clinica Universitaria de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate Time Frame: 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare the efficacy of velcade and dexamethasone with chemotherapy combination VBMCP/VBAD Time Frame: 1 year	1 year
Evaluate the quality of progenitors cells after treatment with Velcade and dexamethasone Time Frame: 6 months	6 months
Compare the complete response rate after high dose therapy in patients treated with velcade and dexamethasone or VBMCP/VBAD Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Spanish association of Haematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

October 20, 2006

First Submitted That Met QC Criteria