Multiple Myeloma Clinical Trial
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
Summary
The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the FDA. They have not been approved in the combination for multiple myeloma or any other type of cancer. Bortezomib is currently approved by the FDA for the treatment of multiple myeloma. Lenalidomide is approved for use with dexamethasone for patients with multiple myeloma who have received at least one prior therapy and for the treatment of certain types of myelodysplastic syndrome (another type of cancer affecting the blood). Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Please note that Bortezomib and Lenalidomide are provided to patients participating in this trial at no charge. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as a high-dose conditioning treatment prior to stem cell transplantation. Cyclophosphamide is used, either alone, or in combination with other drugs, to treat multiple myeloma. These drugs have been used in other multiple myeloma studies and information from those studies suggests that this combination of therapy may help to treat newly diagnosed multiple myeloma.
In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others.
Full Description
After screening procedures determine if a patient is eligible for this research study, the patient will be randomized into one of the study groups: lenalidomide, bortezomib and dexamethasone without autologous stem cell transplantation, followed by lenalidomide maintenance (Arm A) or lenalidomide, bortezomib and dexamethasone with autologous stem cell transplantation, followed by lenalidomide maintenance (Arm B). There is an equal chance of being placed in either group.
All participants will receive one cycle of lenalidomide, bortezomib and dexamethasone treatment before being randomized to Arm A or Arm B.
Participants in Arm A will receive two additional cycles of lenalidomide, bortezomib and dexamethasone prior to stem cell collection. If randomized to Arm A, the subject will undergo stem cell collection, followed by five cycles of lenalidomide, bortezomib and dexamethasone. This will be followed by lenalidomide maintenance treatment until disease progression.
Participants in Arm B will receive two additional cycles of lenalidomide, bortezomib and dexamethasone prior to stem cell collection. If randomized to Arm B, the subject will undergo stem cell collection and autologous stem cell transplantation, followed by two cycles of lenalidomide, bortezomib and dexamethasone. This will be followed by lenalidomide maintenance treatment until disease progression.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Multiple Myeloma, according to the International Myeloma Foundation 2003 Diagnostic Criteria
Documented symptomatic myeloma, with organ damage related to myeloma with laboratory assessments performed within 21 days of registration
Myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains.
ECOG performance status = 2
Negative HIV blood test
Voluntary written informed consent
Exclusion Criteria:
Pregnant or lactating female
Prior systemic therapy for MM (localized radiotherapy allowed if at least 7 days before study entry, corticosteroids allowed if dose = equivalent of 160 mg dexamethasone over 2 weeks)
Primary amyloidosis (AL) or myeloma complicated by amylosis
Receiving any other investigational agents
Known brain metastases
Poor tolerability or allergy to any of the study drugs or compounds of similar composition
Platelet count <50,000/mm3, within 21 days of registration
ANC <1,000 cells/mm3, within 21 days of registration
Hemoglobin <8 g/dL, within 21 days of registration
Hepatic impairment (>/= 1.5 x institutional ULN or AST (SGOT), ALT (SGPT), or alkaline phosphatase >2 x ULN). Patients with benign hyperbilirubinemia are eligible.
Renal insufficiency (serum creatinine >2.0 mg/dl or creatinine clearance <50 ml/min, within 21 days of registration)
Respiratory compromise (DLCO < 50%)
Clinical signs of heart or coronary failure or LVEF < 40%. Myocardial infarction within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system abnormalities
Intercurrent illness including, but not limited to ongoing or active severe infection, known infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements
Previous history of another malignant condition except for basal cell carcinoma and stage I cervical cancer. If malignancy was experienced more than 2 years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion.
Inability to comply with an anti-thrombotic treatment regimen
Peripheral neuropathy >/= Grade 2
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There are 37 Locations for this study
Birmingham Alabama, 35294, United States
Tucson Arizona, 85724, United States
Duarte California, 91010, United States
La Jolla California, , United States
San Francisco California, 94143, United States
Stanford California, 94305, United States
Denver Colorado, 80218, United States
Gainesville Florida, 32608, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Boise Idaho, 83712, United States
Chicago Illinois, 60637, United States
New Orleans Louisiana, 70121, United States
Brewer Maine, 04412, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Hyannis Massachusetts, 02601, United States
Newton Massachusetts, , United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Jackson Mississippi, 39216, United States
Concord New Hampshire, , United States
Hooksett New Hampshire, , United States
Laconia New Hampshire, , United States
Brooklyn New York, , United States
Buffalo New York, 14263, United States
Lake Success New York, 11042, United States
New York New York, 10021, United States
New York New York, 10029, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43210, United States
Portland Oregon, , United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Salt Lake City Utah, , United States
Seattle Washington, 98109, United States
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