Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide
Summary
The main purpose of this study is to see whether pomalidomide can help people with myeloma. Researchers also want to find out if pomalidomide is safe and tolerable.
Description
There are two parts to this study:
- The first part of this study (Phase 1) will determine a safe dose of the medication cyclophosphamide in combination with pomalidomide and dexamethasone.
- Once the safest dose has been determined, this study (Phase 2) will look to see the difference in effectiveness of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide for the treatment of patients who have myeloma, which has relapsed to or become refractory (not responding) to prior treatment.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Myeloma
Intervention
Pomalidomide, Dexamethasone, Cyclophosphamide
Location
University of California San Francisco
San Francisco
California
United States
94143
Status
Recruiting
Source
H. Lee Moffitt Cancer Center and Research Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01432600
- Information obtained from ClinicalTrials.gov on February 27, 2013
Medical and Biotech [MESH] Definitions
Myeloma Proteins
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
Cyclophosphamide
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
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.
Dexamethasone
An anti-inflammatory 9-fluoro-glucocorticoid.
Mesna
A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE.
Clinical Trials
IFM2009-02-Pomalidomide and Dexamethasone Phase 2 Myeloma
The purpose of this study is to evaluate the response to pomalidomide and dexamethasone in relapse and refractory MM patients who are progressive and did not achieve at least a partial res...
The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamid...
The purpose of this study is to compare bortezomib, dexamethasone and cyclophosphamide to bortezomib and dexamethasone alone.
The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that h...
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in differ...
PubMed Articles
Novel agents are considered standard components of induction therapy for newly diagnosed patients with multiple myeloma. We retrospectively compared the results of three consecutive phase 2 clinical t...
Pomalidomide therapy for myeloma.
Introduction: The Office of National Statistics (London, UK) has reported 4040 new patients in the year 2007, with an annual age standardized incidence rate of 4.8 per 100,000 population (range 4.7 -...
Patients with multiple myeloma progressing on current therapies have limited treatment options. Pomalidomide (CC4047), an immunomodulatory drug, has significant activity in relapsed myeloma and previo...
Pomalidomide: First Global Approval.
Pomalidomide (Pomalyst(®)) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide...
We studied 174 consecutive patients with relapsed refractory multiple myeloma (MM) enrolled on a phase II clinical trial of pomalidomide plus low-dose dexamethasone at Mayo Clinic. Extramedullary dise...
