Return to List

Study Summary
No. 2003-0751:.......Blood And Marrow Transplantation......Sergio A. Giralt......Stem Cell Transplantation and Cellular Therapy
.
Study Summary Title
Study Summary
Number:		2003-0751
Study Title:A PHASE II TRIAL OF BORTEZOMIB (VELCADE) AFTER ALLOGENEIC PERIPHERAL BLOOD STEM CELL OR BONE MARROW TRANSPLANTATION FOR PATIENTS WITH MULTIPLE MYELOMA
.
Physician New Patient Referral
Name:Sergio A. GiraltPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
.
General Information
Disease Group:Blood And Marrow TransplantationSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Patients may receive cycles 2 and 3 from their local physician, but must
receive their evaluation prior to cycle 3 at MDACC. Evaluation and treatment
for cycles 1, 4 and final response will be performed at MDACC. Every 1-3 months
while on follow up.
Treatment
Agents:		PS-341Home Care:All standard of care.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		None expected.
Description/
Intervention:		The goal of this clinical research study is to learn if Bortezomib (Velcade)
can help to control the disease in patients who have received a stem cell
transplant from a related or unrelated donor and whose disease has either not
gone into complete remission or whose disease has come back. The safety of
this treatment will also be studied.
.
Study Objectives / Outcomes
Primary Objective
1. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma.

Secondary Objective
2.To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation.
.
Study Status Information
Study Activation / Registration Date:01/06/2004
IRB Review and Approval Date:11/19/2003
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients with Multiple Myeloma at least 3 months post allogeneic transplant who either failed to achieve a complete remission or are relapsing.

2) Allograft performed from a related donor who is HLA-compatible (5/6 or 6/6), or class I serologic match and class II molecular matched unrelated donor).

3) Zubrod PS<2, life expectancy is not severely limited by concomitant illness.

4) Patient willing and able to sign informed consent.

5) Patients less than 70 years of age.
Exclusion Criteria:1) Active CNS disease.

2) Uncontrolled acute or chronic GVHD.
.
Links
Registration Number: NCT00504634
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center