VELCADEXA: Velcade and Dexamethasone in Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00391157
First received: October 20, 2006
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Velcade/Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VELCADEXA: A National, Multi-Center, Open-Label Study of Pretransplant Induction With Alternating VELCADE and Dexamethasone (VEL/Dex) in Younger (< 65 Yrs) Untreated Multiple Myeloma Patients.

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the efficacy of velcade and dexamethasone with chemotherapy combination VBMCP/VBAD [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluate the quality of progenitors cells after treatment with Velcade and dexamethasone [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Compare the complete response rate after high dose therapy in patients treated with velcade and dexamethasone or VBMCP/VBAD [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2005
Study Completion Date: January 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Velcade/Dexamethasone
    Velcade 1,3 mg/m2 on days 1, 4, 8 and 11
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391157

Locations
Spain
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain
Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital Clínic
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital General de Segovia
Segovia, Spain
Hospital La Fe
Valencia, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Bladé Joan, Dr Hospital Clinic of Barcelona
  More Information

Additional Information:
Publications:
Longo D. Plasma cell disorders. In: Fauce A, et al. Ed. Harrison's Principles of Internal Medicine. 14th Ed. New York, New York: Mc Graw-Hill; 1998: 712-718.
Greenlee RT, Murray T, Bolden S , Wingo PA. Cancer Statistics, 2000. CA Cancer J Clin 2000; 50: 7-33
Smith ML, Newland AC. Treatment of myeloma. QJM 1999;92:11-14
Bataille R, Harousseau JL. Multiple Myeloma. N Eng J Med 1997; 336:1657-1664.
Alexanian R, Dimopoulos M. Drug therapy: the treatment of multiple myeloma. N Eng J Med 1994;330:484-489.
Sherr CJ. Cancer cell cyecles. Science 1996;274:1672-1677

Responsible Party: pethema
ClinicalTrials.gov Identifier: NCT00391157     History of Changes
Other Study ID Numbers: 2005-000186-19, VELCADEXA
Study First Received: October 20, 2006
Last Updated: September 17, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Múltiple Myeloma
Transplant
Patients <65 years.

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on July 23, 2014