Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
Status: Recruiting
Phase: Phase 3
Diagnosis: Multiple Myeloma
NCT ID: NCT01208662
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-106
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.
Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital
Overall PI:
David Avigan, MD,
Beth Israel Deaconess Medical Center
Site-responsible Investigators:
Noopur Raje, MD,
Massachusetts General Hospital
Paul Richardson, MD,
Dana-Farber Cancer Institute
Contacts:
Dana-Farber Cancer Institute:
Muriel Gannon, 617-632-4597,
mgannon@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
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
Exclusion Criteria:
- 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 (bilirubin >2 mg/dL or AST (SGOT), ALT (SGPT), or alkaline
phosphatase >2 x ULN)
- 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