Clinical Trial Detail

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. 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.

Ages Eligible for Study: 18 Years to 65 Years

Genders Eligible for Study: Both

- 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

Other eligibility criteria may apply.

- Pregnant or lactating female

- Prior systemic therapy for MM (localized radiotherapy allowed if >/= 2 weeks 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 >2.5 mg/dl or creatinine clearance <60 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

- Inability to comply with an anti-thrombotic treatment regimen

- Peripheral neuropathy >/= Grade 2

Other exclusion criteria may apply.