Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
Summary
The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.
Description
- Since we are looking for the highest doses of the combined study drugs that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma not everyone who participates will receive the same dose of the study drug. The dose the participant receives will depend on the number of participants who have been in the study before them and if they have tolerated their doses.
- Plerixafor will be given as an injection under the skin on days 1, 2, 4 and 5. Participants will receive plerixafor and bortezomib on days 3 and 6 and bortezomib alone on days 10 and 13. Bortezomib is administered intravenously. Each treatment cycle will last 21 days.
- The cycles will be repeated for up to 8 cycles as long as the participant does not have any severe or unmanageable side effects as the disease is responding to the study drug.
- While receiving study drugs and before the start of each study cycle, participants will come to the clinic and the following will be performed: physical exam, questions about current health and current medications, blood work, urine sample, x-rays (if deemed necessary) and EKG.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Multiple Myeloma
Intervention
Plerixafor (AMD3100), bortezomib
Location
Dana-Farber Cancer Institute
Boston
Massachusetts
United States
02115
Status
Recruiting
Source
Dana-Farber Cancer Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00903968
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Leukemia, Plasma Cell
A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.
Myeloma Proteins
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
Bence Jones Protein
An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.
Hla-c Antigens
Class I human histocompatibility (HLA) antigens encoded by a small cluster of structural genes at the C locus on chromosome 6. They have significantly lower immunogenicity than the HLA-A and -B determinants and are therefore of minor importance in donor/recipient crossmatching. Their primary role is their high-risk association with certain disease manifestations (e.g., spondylarthritis, psoriasis, multiple myeloma).
Multiple Myeloma
A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.
Clinical Trials
Mobilization of Stem Cells With AMD3100 in Multiple Myeloma Patients
The purpose of this study is to determine whether the combination of AMD3100 and G-CSF (filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in m...
Patients with non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) will be assigned to one of 2 arms based on the immunophenotype of their lymphoma. (A)Patients with CD20(-) lymphoma wi...
Bortezomib Retreatment in Multiple Myeloma
The purpose of this study is to test the safety and effectiveness of a drug called bortezomib when administered to patients with multiple myeloma who have previously responded to a bortezo...
A Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma
The purpose of this study is to describe the safety and effect of ATN-224 in combination with bortezomib (Velcade®) in patients with Multiple Myeloma who are relapsed from or refractory t...
Rationale: Giving colony-stimulating factors, such as G-CSF and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Purpose: T...
PubMed Articles
AMD3100 was originally discovered as an anti-HIV agent effective in inhibiting the replication of HIV in vitro at nanomolar concentrations. We found it to be a potent and selective antagonist of CXCR4...
Studies comparing the efficacy and cost of stem cell mobilization with intermediate-dose CY (ID-CY) and G-CSF against plerixafor and G-CSF, specifically in multiple myeloma (MM) patients treated in th...
Bortezomib-associated fatal liver failure in a haemodialysis patient with multiple myeloma.
Context. Bortezomib is a proteasome inhibitor with excellent antimyeloma activity. The most frequent toxic side effects are gastrointestinal, neuropathy and thrombocytopenia. The liver was not conside...
Thromboembolic complications commonly occur in patients with multiple myeloma (MM). The risk of such complications may be elevated by the use of immunomodulatory agents such as thalidomide and lenalid...
Bendamustine, active in multiple myeloma (MM), is a bifunctional mechlorethamine derivative with alkylating properties. Bortezomib, approved to treat MM, is effective in combination with alkylators. T...
