Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma
Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma
This is a research study for newly diagnosed multiple myeloma or multiple myeloma has
 returned (relapsed). Multiple myeloma is a type of cancer that begins in white blood cells
 called plasma cells. Plasma cells make proteins that help fight infections. Current therapy
 for multiple myeloma includes high dose chemotherapy and autologous (patient's own cells)
 stem cell transplantation.

 There will be two parts (or phases) to this study:

 The purpose of the first part is to find the highest dose of a drug called lenalidomide
 (Revlimid®) that can be given in combination with high dose melphalan without causing severe
 adverse events.

 The purpose of the second part is to find out the effects of this treatment (good and bad) on
 multiple myeloma patients.
Lenalidomide is a drug that interferes with the development of tiny blood vessels that help
 tumors grow. Lenalidomide in combination with dexamethasone is approved by the Food and Drug
 Administration (FDA) for the treatment of relapsed multiple myeloma. It is also approved for
 the treatment of specific types of myelodysplastic syndrome (MDS), another blood cancer.
 Other research studies using lenalidomide in combination with other drugs in subjects with
 newly diagnosed multiple myeloma also show good response rate.

 High dose melphalan is approved by the FDA and is commonly used in multiple myeloma treatment
 prior to stem cell transplantation. This combination of lenalidomide, high-dose melphalan and
 stem cell transplantation has not been studied in newly diagnosed and relapsed multiple
 myeloma, so it is considered experimental. In research studies, "experimental" refers to a
 drug or procedure that has undergone basic laboratory testing and received approval from the
 US Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may
 be approved by the FDA for use in one disease or condition, but be considered experimental in
 other diseases or conditions.

 In this study, lenalidomide will be given together with melphalan (chemotherapy) with the
 hope that more disease will be killed before the stem cell transplant. Three months after the
 transplant, patients will take lenalidomide again with the hope that this will help prolong
 the time when the disease is in remission.
Inclusion Criteria:

 -  Phase I: Patients with diagnosis of multiple myeloma at any stage of disease
 undergoing high dose chemotherapy and stem cell transplantation.

 -  Phase II: Patients with myeloma undergoing a first high dose chemotherapy and stem
 cell transplantation after achieving at least stable disease following induction
 therapy. Any induction regimen prior to transplantation is allowed. No more than 2
 prior lines of therapy prior to transplantation are allowed.

 -  All previous therapy not associated with peripheral blood stem cell transplant,
 including radiation, hormonal therapy, and surgery, must have been discontinued 4
 weeks prior to treatment in this study.

 -  ECOG performance status of </= 2 at study entry

 -  Laboratory test results within protocol-specified ranges

 -  All study participants must be registered into the mandatory RevAssist® program, and
 be willing and able to comply with the requirements of RevAssist®

 -  Females of childbearing potential must have negative pregnancy test within 24 hours of
 first prescription for lenalidomide and must commit to either continued abstinence
 from heterosexual intercourse or begin TWO acceptable methods of birth control.

 -  Able to take aspirin daily as prophylactic anticoagulation

 -  Subject must have the minimum stem cell dose of 5.0 x 10^6 CD34+ cells/kg collected.

 Exclusion Criteria:

 -  Pregnant or breast feeding females

 -  History of intolerance or resistance to lenalidomide

 -  Known hypersensitivity to thalidomide

 -  The development of erythema nodosum if characterized by a desquamating rash while
 taking thalidomide or similar drugs.

 -  Known seropositive for or active viral infection with human immunodeficiency vrus
 (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
 seropositive because of hepatitis b virus vaccine are eligible.