Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma
Multiple Myeloma in Relapse
About this trial
This is an interventional treatment trial for Multiple Myeloma in Relapse
Eligibility Criteria
- Histologically confirmed diagnosis of symptomatic multiple myeloma; relapsed disease is myeloma that has previously responded to prior therapy (MR or better) and subsequently progressed
Patient must have measurable disease or non-measurable disease, defined as one or more of the following holding true:
Measurable disease:
- Serum M-protein >= 1.0 g/dL (>= 0.5 g/dL for IgA or IgM myeloma) and/or
- Urine M-protein >= 200 mg/24 hours and/or
- Involved serum free light chain level >= 10 mg/dL AND an abnormal serum free light chain ratio
For non-measurable disease:
- Baseline marrow burden of myeloma of at least 30%
Progression on lenalidomide as part of first line therapy (lenalidomide-refractory disease)
* Lenalidomide-refractory disease is defined as disease progression on or progression within 60 days of the last dose of a lenalidomide-based treatment; patients should have received at least 2 cycles of a lenalidomide-based regimen to be evaluable for refractoriness; examples: 1) progression on lenalidomide maintenance therapy after initial induction +/- consolidation; 2) initial response followed by progression on continuous lenalidomide-dexamethasone +/- elotuzumab or daratumumab
- Pomalidomide naive disease
Proteasome inhibitor naive or sensitive disease; proteasome inhibitor sensitive disease is defined as a PR or better to prior proteasome inhibitor-based therapy that is maintained for >= 60 days from the last dose of the proteasome inhibitor
* A patient who receives induction therapy with lenalidomide, bortezomib and dexamethasone and achieves a PR or better but subsequently progresses on continued lenalidomide or lenalidomide-dexamethasone would be eligible provided the progression occurs 60 days or more after discontinuation of the bortezomib; similarly, ixazomib exposure is allowed provided they meet the definition of proteasome inhibitor sensitive disease
- 1 prior line of systemic therapy for multiple myeloma, where a line of therapy for myeloma is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy); a new line of therapy begins when a planned therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, disease relapse or treatment-related toxicity (e.g. a patient is progressing in the face of lenalidomide maintenance therapy and has bortezomib and dexamethasone added into their regimen); a new line of therapy also begins when a planned treatment-free interval is interrupted by the need to start treatment due to disease relapse/progression (e.g. a patient with relapsed myeloma achieves a partial response after a planned 8 cycles of cyclophosphamide, bortezomib and dexamethasone, enjoys an 8-month period off therapy but then experiences disease progression requiring re-initiation of therapy)
- Allogeneic stem cell transplantation is allowed provided the patient is >= 1 year from transplant at time of registration, is not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft versus host disease, and no evidence of active infection
- No other chemotherapy or radiation therapy within 14 days prior to registration
- No investigational therapy within 14 days prior to registration
- No major surgery within 28 days prior to registration
- No G-CSF (filgrastim) or GM-CSF (sargramostim) within 7 days of registration or pegfilgrastim within 14 days of registration to meet eligibility criteria
- No platelet transfusions within 7 days of registration to meet eligibility criteria; Note: red blood cell transfusions are allowed at any time
A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Women of childbearing potential:
- Must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mlU/ml no more than 14 days prior to registration and must agree to repeat this test within 24 hours of starting pomalidomide
- Must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, before starting pomalidomide
- Must agree to ongoing pregnancy testing
- Must agree to not become pregnant or breast feed a child during treatment on this protocol
- Men must practice complete abstinence or agree to use a condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy
- Note: All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
- Platelet count >= 50 x 10^9/L
- Calculated (Calc.) creatinine clearance >= 30 mL/min; calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection
- Total bilirubin < 1.5 x upper limits of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limits of normal (ULN)
- Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
Patients cannot have:
- Central nerve system involvement
- Primary refractory multiple myeloma, where primary refractory multiple myeloma is defined as disease that is nonresponsive - patients who have never achieved a minimal response (MR) or better - with any therapy over the course of their disease; it includes patients who never achieve MR or better in whom there is no significant change in M-protein and no evidence of clinical progression as well as patients who meet criteria for true progressive disease (PD)
- Primary or secondary plasma cell leukemia
- Light-chain (AL) amyloidosis or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
Known active hepatitis C based on:
- +hepatitis C virus (HCV) antibody (confirmed)
- +HCV RNA
- Liver disease with history of positive serology
- Note: patients with a prior history of hepatitis C that has been successfully eradicated with antiviral therapy are eligible
- Known hepatitis B surface antigen positivity
- Previous hypersensitivity to any of the components of the study treatment
- Prior history of erythema multiforme with thalidomide or lenalidomide treatment
- =< grade 2 peripheral neuropathy
Adequate cardiac function, defined as:
- No electrocardiogram (EKG) evidence of acute ischemia
- No EKG evidence of active, clinically significant conduction system abnormalities
- No EKG evidence of > grade 2 (> 480 ms) corrected QT (QTc) prolongation
- Prior to study entry, any EKG abnormality at screening not felt to put the patient at risk has to be documented by the investigator as not medically significant
- No uncontrolled angina or severe ventricular arrhythmias
- No clinically significant pericardial disease
- No history of myocardial infarction within 6 months prior to registration
- No class 3 or higher New York Heart Association congestive heart failure
No strong inducers of cytochrome P450 (CYP) 3A4 or CYP1A2 or strong inhibitors of CYP3A4 or CYP1A2 within 14 days prior to registration
- Note: Ixazomib is a substrate of CYP3A4 and CYP1A2
Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following:
- No history of acquired immunodeficiency syndrome (AIDS)-defining conditions or other HIV related illness
- Cluster of differentiation (CD)4+ cells nadirs > 350/mm^3 within 28 days prior to registration
- Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm^3 within 28 days prior to registration
- Note: HIV+ patients who enroll on this study and are assigned to treatment with ixazomib may need to modify their anti-retroviral therapy prior to receiving protocol therapy if they are on strong inducers or potent inhibitors of cytochrome P450 3A4
- RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients randomized to Arm 1 may opt to switch to the 3-drug regimen following disease progression; these patients must be re-registered to the study and meet the eligibility criteria below
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patient must have measurable disease or non-measurable disease after progression on pomalidomide + dexamethasone, defined as one or more of the following holding true:
* Measurable disease:
- Serum M-protein >= 0.5 g/dL and/or
- Urine M-protein >= 200 mg/24 hours and/or
Involved serum free light chain level >= 10 mg/dL AND an abnormal serum free light chain ratio
* For non-measurable disease:
- Marrow burden of myeloma of at least 30%
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2):
Women of childbearing potential:
** Must have a negative serum or urine pregnancy test within 72 hours prior to re-registration
** Must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, before starting pomalidomide
** Must agree to ongoing pregnancy testing
** Must agree to not become pregnant or breast feed a child during treatment on this protocol
- Men must practice complete abstinence or agree to use a condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy
- Note: All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
- RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status 0-2
- RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
- RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Platelet count >= 50 x 10^9/L
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Calc. creatinine clearance >= 30 mL/min
* Calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection
- RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin < 1.5 x upper limits of normal (ULN)
- RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST and ALT < 2.5 x upper limits of normal (ULN)
- RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
- RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): =< grade 2 peripheral neuropathy
- RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): No strong inducers of cytochrome P450 (CYP) 3A4 or CYP1A2 or strong inhibitors of CYP3A4 or CYP1A2 * Note: Ixazomib is a substrate of CYP3A4 and CYP1A2
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Regional Hospital
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- UC San Diego Moores Cancer Center
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- MedStar Georgetown University Hospital
- Memorial Health University Medical Center
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Mountain States Tumor Institute
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Medical Center
- Walter Knox Memorial Hospital
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Alphonsus Medical Center-Nampa
- Saint Luke's Mountain States Tumor Institute - Nampa
- Kootenai Cancer Center
- Kootenai Cancer Clinic
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- University of Illinois
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- NorthShore University HealthSystem-Glenbrook Hospital
- Ingalls Memorial Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Good Samaritan Regional Health Center
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Siouxland Regional Cancer Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Wesley Medical Center
- Cancer Center of Kansas - Winfield
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Penobscot Bay Medical Center
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- Mercy Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- IHA Hematology Oncology Consultants-Brighton
- Saint Joseph Mercy Brighton
- IHA Hematology Oncology Consultants-Canton
- Saint Joseph Mercy Canton
- Caro Cancer Center
- IHA Hematology Oncology Consultants-Chelsea
- Saint Joseph Mercy Chelsea
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Henry Ford Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Green Bay Oncology - Escanaba
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Hope Cancer Clinic
- Saint Mary Mercy Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Toledo Clinic Cancer Centers-Monroe
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Ascension Providence Hospitals - Novi
- Henry Ford Medical Center-Columbus
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Munson Medical Center
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Metro Health Hospital
- Huron Gastroenterology PC
- IHA Hematology Oncology Consultants-Ann Arbor
- Essentia Health - Deer River Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Essentia Health Hibbing Clinic
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Essentia Health Virginia Clinic
- Saint Louis Cancer and Breast Institute-Ballwin
- Parkland Health Center-Bonne Terre
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Saint Luke's Hospital of Kansas City
- Heartland Hematology and Oncology Associates Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Delbert Day Cancer Institute at PCRMC
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- University of New Mexico Cancer Center
- Roswell Park Cancer Institute
- Northwell Health/Center for Advanced Medicine
- North Shore University Hospital
- Long Island Jewish Medical Center
- Memorial Sloan Kettering Cancer Center
- State University of New York Upstate Medical University
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- East Carolina University
- Southeastern Medical Oncology Center-Jacksonville
- Rex Hematology Oncology Associates-Blue Ridge
- Iredell Memorial Hospital
- Wake Forest University Health Sciences
- Strecker Cancer Center-Belpre
- Adena Regional Medical Center
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Dublin Methodist Hospital
- Central Ohio Breast and Endocrine Surgery
- Mount Carmel Grove City Hospital
- Fairfield Medical Center
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Mercy Health Perrysburg Cancer Center
- Southern Ohio Medical Center
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Saint Ann's Hospital
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Pocono Medical Center
- Lehigh Valley Hospital-Hazleton
- Gibbs Cancer Center-Gaffney
- Gibbs Cancer Center-Pelham
- Spartanburg Medical Center
- MGC Hematology Oncology-Union
- University of Virginia Cancer Center
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- PeaceHealth Saint Joseph Medical Center
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Providence Regional Cancer Partnership
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- PeaceHealth Saint John Medical Center
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- Swedish Medical Center-Cherry Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- Evergreen Hematology and Oncology PS
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- Providence Regional Cancer System-Yelm
- West Virginia University Healthcare
- Duluth Clinic Ashland
- Marshfield Clinic-Chippewa Center
- Marshfield Medical Center-EC Cancer Center
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Gundersen Lutheran Medical Center
- Marshfield Clinic - Ladysmith Center
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Saint Vincent Hospital Cancer Center at Marinette
- Marshfield Medical Center-Marshfield
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Marshfield Medical Center-Rice Lake
- HSHS Saint Nicholas Hospital
- Marshfield Clinic Stevens Point Center
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Green Bay Oncology - Sturgeon Bay
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Marshfield Clinic-Wausau Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (pomalidomide, dexamethasone)
Arm II (pomalidomide, dexamethasone, ixazomib)
Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.