Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary Objective:

1\. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma.

Secondary Objective

1\. To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma

NCT00084747

Multiple Myeloma and Plasma Cell Neoplasm

COMPLETED PHASE1/PHASE2

Expanded Access Protocol (EAP) to Provide Bortezomib to Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma

NCT00440635

Multiple Myeloma

COMPLETED

Nonmyeloablative Allogeneic Stem Cell Transplant Followed by Bortezomib in High-risk Multiple Myeloma Patients

NCT02308280

Multiple Myeloma High-Risk Cancer

COMPLETED PHASE2

Velcade (Bortezomib) Consolidation After Transplant

NCT01539083

Multiple Myeloma

COMPLETED PHASE3

Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

NCT00153920

Multiple Myeloma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Bortezomib (velcade) is a new drug that works by blocking a structure in the cells called proteasome. This proteasome acts like a system that eliminates abnormal or old proteins from the cells. Cancer cells may be sensitive to drugs like bortezomib (velcade), because tumor cells have more abnormal proteins than normal cells. Bortezomib (velcade) enters the tumor cells and affects the way they divide. When cancer cells cannot divide, they die.

You will have blood (about 2 tablespoons) and bone marrow testing done about every 2-3 months to determine your response and tolerance to treatment. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.

You will receive bortezomib (velcade) as an infusion into a vein over 5-10 minutes twice a week for 2 weeks. You will then rest for 10 to 17 days. This 21-28 day period makes up 1 cycle. You will complete up to a total of 4 cycles. Courses 2 and 3 might be given under supervision of your local physician however the principal investigator will do necessary treatment dose adjustments and new set of treatment orders will be provided to your physician. Treatment evaluations will be under the supervision of the principal investigator.

You will have a physical exam and routine blood tests (about 2 tablespoons) before each dose of bortezomib (velcade). Blood (about 2 tablespoons) and urine tests to determine response to treatment will be performed once a month, as well as blood tests to look at side effects of treatment, will be performed at least once a week and more frequently if medically necessary.

You will be taken off study if the disease gets worse or intolerable side effects occur. You will be called every 3 months for at least 1 year after the last dose of bortezomib (velcade) to see how you are doing.

This is an investigational study. Bortezomib (velcade) is commercially available and indicated for the treatment of myeloma. A total of 28 patients will participate in this study. All will be enrolled at M. D. Anderson.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bortezomib

1 mg/m\^2 intravenous (IV) Days 1, 4, 8, and 11.

Group Type EXPERIMENTAL

Bortezomib

Intervention Type DRUG

1 mg/m\^2 IV On Days 1, 4, 8, and 11.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bortezomib

1 mg/m\^2 IV On Days 1, 4, 8, and 11.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Velcade PS-341

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with multiple myeloma at least 3 months post allogeneic transplant who either failed to achieve a complete remission or are relapsing.
* 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).
* Zubrod Points Scale (PS) \< 2, life expectancy is not severely limited by concomitant illness.
* Patient willing and able to sign informed consent.
* Patients less than 70 years of age.