Know Cancer

forgot password

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.

Phase 2
18 Years
64 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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.

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

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consent may be withdrawn by the patient at any time without prejudice to their future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

- 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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Bladé Joan, Dr

Investigator Role:

Study Chair

Investigator Affiliation:



Spain: Ministry of Health

Study ID:




Start Date:

August 2005

Completion Date:

January 2008

Related Keywords:

  • Multiple Myeloma
  • Múltiple Myeloma
  • Transplant
  • Patients <65 years.
  • Multiple Myeloma
  • Neoplasms, Plasma Cell