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.

View Full Description

Full Description

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.

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. Randomization was stratified by International Staging System (ISS) disease stage (I, II, or III) and cytogenetics (high-risk [presence of 17p deletion, t(4;14), or t(14;16) on fluorescence in-situ hybridization], standard-risk [absence of high-risk abnormalities], or undetermined [test failure]) assessed locally in a screening bone marrow sample, with positivity cut-offs per institutional standards.

View Eligibility Criteria

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 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 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

729

Study ID:

NCT01208662

Recruitment Status:

Active, not recruiting

Sponsor:

Paul Richardson, MD

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 37 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Arizona Comprehensive Cancer Center
Tucson Arizona, 85724, United States
City of Hope
Duarte California, 91010, United States
University of California at San Diego
La Jolla California, , United States
University of California, San Francisco
San Francisco California, 94143, United States
Stanford University
Stanford California, 94305, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
University of Florida
Gainesville Florida, 32608, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Emory University
Atlanta Georgia, 30322, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise Idaho, 83712, United States
University of Chicago
Chicago Illinois, 60637, United States
Ochsner Foundation Clinic
New Orleans Louisiana, 70121, United States
Eastern Maine Medical Center
Brewer Maine, 04412, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Cape Cod Healthcare
Hyannis Massachusetts, 02601, United States
Newton-Wellesley Hospital
Newton Massachusetts, , United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
New Hampshire Oncology and Hematology
Concord New Hampshire, , United States
New Hampshire Oncology and Hematology
Hooksett New Hampshire, , United States
New Hampshire Oncology and Hematology
Laconia New Hampshire, , United States
State University of New York Downstate Medical Center
Brooklyn New York, , United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
North Shore Long Island Jewish Health System
Lake Success New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Columbia University
New York New York, 10032, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Duke University
Durham North Carolina, 27710, United States
Wake Forest University
Winston-Salem North Carolina, 27157, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
Oregon Health and Sciences
Portland Oregon, , United States
University of Pennsylvania Medical Center
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Vanderbilt University
Nashville Tennessee, 37203, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Baylor College of Medicine
Houston Texas, 77030, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City Utah, , United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

729

Study ID:

NCT01208662

Recruitment Status:

Active, not recruiting

Sponsor:


Paul Richardson, MD

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.