Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65

• Status: Active, not recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paul G. Richardson, MD
• Collaborators: Barbara Ann Karmanos Cancer Institute; Baylor College of Medicine; Beckman Research Institute; Beth Israel Deaconess Medical Center; Cape Cod Healthcare; Cape Cod Hospital; Celgene Corporation; City of Hope Medical Center; Columbia University; Duke University; Eastern Maine Medical Center; Emory University; Fox Chase Cancer Center; Fred Hutchinson Cancer Research Center; H. Lee Moffitt Cancer Center and Research Institute; Huntsman Cancer Institute; Icahn School of Medicine at Mount Sinai; M.D. Anderson Cancer Center; Massachusetts General Hospital; Memorial Sloan Kettering Cancer Center; Millennium Pharmaceuticals, Inc.; Newton-Wellesley Hospital; Northwell Health; Ochsner Health System; Ohio State University; OHSU Knight Cancer Institute; Roswell Park Cancer Institute; Stanford University; State University of New York - Downstate Medical Center; UNC Lineberger Comprehensive Cancer Center; University of Alabama at Birmingham; University of Arizona; University of California, San Diego; University of California, San Francisco; University of Chicago; University of Florida; University of Michigan; University of Mississippi Medical Center; University of Pittsburgh; University of Pittsburgh Medical Center; University of Texas Southwestern Medical Center; Vanderbilt University; Vanderbilt University Medical Center; Wake Forest Baptist Health; Wake Forest University Health Sciences
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

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
• 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 dosedexamethasone 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