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Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02516423
Recruitment Status : Active, not recruiting
First Posted : August 5, 2015
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Biologics, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid with zoledronic acid alone to see how well they work when given after radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more effective, and whether adding these treatments after radiation therapy is more effective than radiation therapy alone in treating patients with solitary plasmacytoma of bone.

Condition or disease Intervention/treatment Phase
Solitary Osseous Plasmacytoma Drug: ixazomib Drug: lenalidomide Drug: dexamethasone Drug: zoledronic acid Phase 3

Detailed Description:

This phase III randomized clinical trial was designed to assess the impact of the addition of ixazomib, lenalidomide, and dexamethasone to zoledronic acid the multiple myeloma progression rate at 5 years. A dynamic allocation procedure will be used to allocate an equal number of patients to each of the treatment arms. This procedure will balance the number of patients which falls into each of the following categories between the two treatment arms:

  1. % of abnormal plasma cells in the bone marrow: 5-9%
  2. age < 60; % of abnormal plasma cells in the bone marrow < 5%; and monoclonal protein/clonal light chains present in the blood or urine
  3. age < 60; % of abnormal plasma cells in the bone marrow < 5% and no monoclonal protein/clonal light chains present in the blood or urine, (MRD+) minimal residual disease
  4. age ≥ 60; % of abnormal plasma cells in the bone marrow < 5%; and monoclonal protein/clonal light chains present in the blood or urine
  5. age ≥ 60; % of abnormal plasma cells in the bone marrow < 5% and no monoclonal protein/clonal light chains present in the blood or urine, (MRD+) minimal residual disease

The primary and secondary objectives are described below.

Primary objective

To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in increasing the time before progression to multiple myeloma.

Secondary objectives

  1. To assess changes in minimal residual disease [MRD] by flow cytometry from study entry, at the completion of treatment, and at 1 year post registration.
  2. To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in extending overall survival.
  3. To examine the pharmacodynamics effects of treatment on biochemical markers of bone formation (osteocalcin bone-specific alkaline phosphatase), resorption (serum CTX), and metabolism (OPG).

Follow-up requirements after documentation of progression to multiple myeloma includes a maximum of five years following registration.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment With Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy
Study Start Date : December 2015
Estimated Primary Completion Date : September 2024


Arm Intervention/treatment
Experimental: ixazomib + lenalidomide + dexamethasone + zoledronic acid
Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
Drug: ixazomib
oral

Drug: lenalidomide
oral

Drug: dexamethasone
oral

Drug: zoledronic acid
IV

Active Comparator: zoledronic acid
Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
Drug: zoledronic acid
IV




Primary Outcome Measures :
  1. Progression-free survival rate [ Time Frame: at 5 years ]

Secondary Outcome Measures :
  1. Changes in minimal residual disease from study entry to the completion of adjuvant treatment (approximately six months post-registration) and at 1 year post-registration [ Time Frame: at 6 and 12 months post-registration ]
  2. Clinical response rate at 12 months post-registration using whole body PET/CT [ Time Frame: at 12 months post-registration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Pre-registration eligibility criteria (Step 0)

  1. Documentation of Disease: Histologic Documentation of Solitary Bone Plasmacytoma

    1. For patients pre-registering after the completion of radiation therapy, documentation of a bone marrow aspirate and biopsy containing <10% clonal plasma cells done at most 28 days prior to start of radiation therapy
    2. For patients pre-registering before the start of radiation therapy, radiation therapy scheduled to begin at most 28 days after a bone marrow aspirate and biopsy were performed containing <10% clonal plasma cells
    3. Participants must have disease that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains or by minimal residual detection. Measurable disease is defined as one or more of the following:

      • serum M protein > 0.5 G/DL, or
      • urine M protein >200 MG/24H, and/or
      • serum FLC assay: involved FLC level > 10 MG/DL with abnormal serum FLC ratio
      • ≥ 50 Plasma cells detectable by multicolor flow cytometry, at a sensitive level of 10^-4
  2. Age ≥ 18 years
  3. ECOG Performance Status 0-2

Registration Eligibility Criteria (Step 1)

  1. Documentation of Disease:

    1. No lytic lesions on skeletal survey and whole body PET/CT other than a single lesion associated with solitary bone plasmacytoma within 28 days prior to registration.
    2. Participants must have disease that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains or by minimal residual detection. Measurable disease is defined as one or more of the following:

      • serum M protein > 0.5 G/DL, or
      • urine M protein >200 MG/24H, and/or
      • serum FLC assay: involved FLC level > 10 MG/DL with abnormal serum FLC ratio
      • ≥ 50 Plasma cells detectable by multicolor flow cytometry, at a sensitive level of 10^-4
  2. Prior Treatment

    1. No major surgery within 21 days of registration with stabilization or resolution of surgical adverse events.
    2. No investigational agent within 21 days prior to registration
    3. No ongoing therapy with corticosteroids greater than 10 mg of prednisone or its equivalent per day. Please note: Inhaled and topical steroids are permitted.
    4. No prior proteasome inhibitor or IMiD use.
    5. Prior bisphosphonate use is permitted.
    6. For all patients:

      • Radiation dose should range from 4500 cGy to 6000 cGy
      • No treatment for this disease following radiation therapy
      • Registration must be completed within 90 days of completion of radiation therapy.
  3. Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown and an agent that has known genotoxic, mutagenic and teratogenic effects.

    1. Females of childbearing potential (FCBP), defined as 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 that is, has not had menses at any time in the preceding 24 consecutive months:

      • must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide.
      • must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
      • must agree to ongoing pregnancy testing.
    2. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy.
  4. ECOG Performance Status 0-2
  5. Required Initial Laboratory Values within 14 days of registration:

    1. Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3
    2. Platelet Count ≥ 75,000/mm^3
    3. Hemoglobin ≥ 10 g/dL
    4. Serum Creatinine < 2.0 mg/dL [176.8 µmol/liter]
    5. Serum calcium ≤ 11.5 mg/dL
    6. Calc. Creatinine Clearance > 50 mL/min
    7. Bilirubin ≤ 1.5 x upper limits of normal (ULN)
    8. AST ≤ 2.5 x upper limits of normal (ULN)
  6. Intercurrent or Recent Illness

    1. If history of prior malignancy, subject should be in complete remission for ≥ 5 years at the time of registration (with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection).
    2. HIV + patients are eligible provided they meet the other eligibility criteria and:

      • CD4+ cells are ≥ 250/mm^3
      • There is no history of AIDS defining conditions other than historically low CD4+ cell count.
      • The following antiretroviral agents are not allowed: zidovudine, stavudine, protease inhibitors, combination pills with pharmacologic boosters.
      • Recommended antiretroviral regimens to avoid PK interactions include strand integrase inhibitors with nucleoside and non-nucleoside reverse transcriptase inhibitors (for example, dolutegravir given with tenofovir and emtricitabine).
    3. Patients with HBV infection are eligible provided they meet the other eligibility criteria and:

      • There is no evidence of hepatic damage related to HBV infection.
      • They have had consistently suppressed HBV viral load to undetectable levels by PCR for a minimum of 12 months.
    4. Patients with HCV infection are eligible provided they meet the other eligibility criteria and:

      • They have previously undergone curative therapy and have no evidence of active HCV infection.
      • They have no evidence of liver damage owing to prior HCV infection.

      Patients with active HCV infection should be referred for HCV treatment and standard radiotherapy for the plasmacytoma.

    5. Patients cannot have:

      • Known allergy to boron or excipients in the formulation.
      • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of study drugs including difficulty swallowing.
      • Infection requiring systemic antibiotic therapy or other serious infection within 14 days before registration.
      • Diarrhea ≥ Grade 1, based on the NCI CTCAE categorization within 14 days of registration
      • Life-threatening illness unrelated to cancer
      • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, pomalidomide, or similar drugs.
  7. Peripheral Neuropathy: ≤ Grade 2 Peripheral Neuropathy
  8. Adequate cardiac function, defined as:

    1. No cardiac arrhythmias within 182 days of registration.
    2. No congestive heart failure (CHF) within 182 days of registration.
    3. No angina or myocardial infarction within 182 days of registration. In view of potential cardiac risk with lenalidomide, patients with stable angina will be excluded.
  9. Concomitant Treatment: Patients cannot be on systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) within 14 days of registration.
  10. QT c< 470 milliseconds (msec) on a 12-lead ECG ≤ 28 days before registration
  11. Dental evaluation within 35 days of registration: Complete dental exam; complete elimination of dental and periodontal pathology including crowns on teeth susceptible to fracture, extraction of non-restorable or periodontally uncorrectable teeth; creation of an oral environment that the patient can efficiently maintain in a high state of health; and oral hygiene instruction to maintain excellent oral health.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516423


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Locations
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United States, Alaska
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Anchorage Oncology Centre
Anchorage, Alaska, United States, 99508
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
University Oncology Associates
Clovis, California, United States, 93611
Epic Care-Dublin
Dublin, California, United States, 94568
Bay Area Breast Surgeons Inc
Emeryville, California, United States, 94608
Epic Care Partners in Cancer Care
Emeryville, California, United States, 94608
California Cancer Center - Fresno
Fresno, California, United States, 93720
Scripps Cancer Center
La Jolla, California, United States, 92037
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Bay Area Tumor Institute
Oakland, California, United States, 94609
Epic Care Cyberknife Center
Walnut Creek, California, United States, 94597
United States, Colorado
Grand Valley Oncology
Grand Junction, Colorado, United States, 81501
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States, 83605
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
Walter Knox Memorial Hospital
Emmett, Idaho, United States, 83617
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States, 83619
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, United States, 83686
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States, 83686
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Memorial Hospital of Carbondale
Carbondale, Illinois, United States, 62902
SIH Cancer Institute
Carterville, Illinois, United States, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Rush University Medical Center
Chicago, Illinois, United States, 60612
Carle on Vermilion
Danville, Illinois, United States, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Radiation Oncology of Northern Illinois
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Springfield Clinic
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States, 62226
Southwest Illinois Health Services LLP
Swansea, Illinois, United States, 62226
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Rush-Copley Healthcare Center
Yorkville, Illinois, United States, 60560
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Springmill Medical Center
Indianapolis, Indiana, United States, 46290
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Woodland Cancer Care Center
Michigan City, Indiana, United States, 46360
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, United States, 46545
Chancellor Center for Oncology
Newburgh, Indiana, United States, 47630
Reid Health
Richmond, Indiana, United States, 47374
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67905
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Lafayette Family Cancer Center-EMMC
Brewer, Maine, United States, 04412
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Mercy Medical Center
Springfield, Massachusetts, United States, 01104
United States, Michigan
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan, United States, 48114
Saint Joseph Mercy Brighton
Brighton, Michigan, United States, 48114
Henry Ford Cancer Institute?Downriver
Brownstown, Michigan, United States, 48183
IHA Hematology Oncology Consultants-Canton
Canton, Michigan, United States, 48188
Saint Joseph Mercy Canton
Canton, Michigan, United States, 48188
Caro Cancer Center
Caro, Michigan, United States, 48723
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan, United States, 48118
Saint Joseph Mercy Chelsea
Chelsea, Michigan, United States, 48118
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, United States, 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan, United States, 48346
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States, 48038
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States, 48124
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States, 48126
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Ascension Saint John Hospital
Detroit, Michigan, United States, 48236
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan, United States, 48054
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, United States, 48503
Genesee Hematology Oncology PC
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, United States, 48236
Lymphoma Clinic of Michigan
Grosse Pointe Woods, Michigan, United States, 48236
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, United States, 48236
Allegiance Health
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
Sparrow Hospital
Lansing, Michigan, United States, 48912
Hope Cancer Clinic
Livonia, Michigan, United States, 48154
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, United States, 48044
Michigan Breast Specialists-Macomb Township
Macomb, Michigan, United States, 48044
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, United States, 48453
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States, 48162
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Lakeland Hospital Niles
Niles, Michigan, United States, 49120
Ascension Providence Hospitals - Novi
Novi, Michigan, United States, 48374
Henry Ford Medical Center-Columbus
Novi, Michigan, United States, 48377
21st Century Oncology-Pontiac
Pontiac, Michigan, United States, 48341
Hope Cancer Center
Pontiac, Michigan, United States, 48341
Newland Medical Associates-Pontiac
Pontiac, Michigan, United States, 48341
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan, United States, 48309
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States, 48604
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Ascension Providence Hospitals - Southfield
Southfield, Michigan, United States, 48075
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, United States, 48312
Saint Joseph Health System-Tawas City
Tawas City, Michigan, United States, 48764
Munson Medical Center
Traverse City, Michigan, United States, 49684
Advanced Breast Care Center PLLC
Warren, Michigan, United States, 48088
Bhadresh Nayak MD PC-Warren
Warren, Michigan, United States, 48093
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, United States, 48093
Macomb Hematology Oncology PC
Warren, Michigan, United States, 48093
Michigan Breast Specialists-Warren
Warren, Michigan, United States, 48093
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, United States, 48661
Metro Health Hospital
Wyoming, Michigan, United States, 49519
Huron Gastroenterology PC
Ypsilanti, Michigan, United States, 48106
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States, 56501
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States, 56537
Essentia Health - Fosston
Fosston, Minnesota, United States, 56542
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Essentia Health - Park Rapids
Park Rapids, Minnesota, United States, 56470
Mayo Clinic
Rochester, Minnesota, United States, 55905
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, United States, 56701
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Sanford Cancer Center Worthington
Worthington, Minnesota, United States, 56187
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, United States, 63011
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States, 65613
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States, 63628
Cox Cancer Center Branson
Branson, Missouri, United States, 65616
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Capital Region Southwest Campus
Jefferson City, Missouri, United States, 65109
Freeman Health System
Joplin, Missouri, United States, 64804
Mercy Hospital Joplin
Joplin, Missouri, United States, 64804
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States, 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64507
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States, 63127
Mercy Hospital Washington
Washington, Missouri, United States, 63090
United States, Montana
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59804
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Norris Cotton Cancer Center-Nashua
Nashua, New Hampshire, United States, 03063
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Sanford South University Medical Center
Fargo, North Dakota, United States, 58103
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, United States, 58401
United States, Ohio
Indu and Raj Soin Medical Center
Beavercreek, Ohio, United States, 45431
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States, 45459
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, United States, 45202
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, United States, 45211
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States, 45236
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, United States, 45242
Mount Carmel East Hospital
Columbus, Ohio, United States, 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Dayton Physicians LLC-Samaritan North
Dayton, Ohio, United States, 45415
Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Delaware Radiation Oncology
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, United States, 45014
Armes Family Cancer Center
Findlay, Ohio, United States, 45840
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Orion Cancer Care
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States, 45005
Dayton Physicians LLC-Wayne
Greenville, Ohio, United States, 45331
Wayne Hospital
Greenville, Ohio, United States, 45331
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
First Dayton Cancer Care
Kettering, Ohio, United States, 45420
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States, 44903
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
OhioHealth Marion General Hospital
Marion, Ohio, United States, 43302
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Dayton Physicians LLC-Signal Point
Middletown, Ohio, United States, 45042
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Newark Radiation Oncology
Newark, Ohio, United States, 43055
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, United States, 43551
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Dayton Physicians LLC-Wilson
Sidney, Ohio, United States, 45365
Springfield Regional Cancer Center
Springfield, Ohio, United States, 45504
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Dayton Physicians LLC-Upper Valley
Troy, Ohio, United States, 45373
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States, 73505
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, United States, 97814
Saint Charles Health System
Bend, Oregon, United States, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, United States, 97015
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, United States, 97914
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Saint Charles Health System-Redmond
Redmond, Oregon, United States, 97756
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States, 17837
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, United States, 17901
Community Medical Center
Scranton, Pennsylvania, United States, 18510
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, United States, 17870
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States, 29341
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
MGC Hematology Oncology-Union
Union, South Carolina, United States, 29379
United States, South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, United States, 76104
M D Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Farmington Health Center
Farmington, Utah, United States, 84025
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
South Jordan Health Center
South Jordan, Utah, United States, 84009
United States, Vermont
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Danville Hematology Oncology
Danville, Virginia, United States, 24541
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Washington
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States, 98520
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue, Washington, United States, 98005
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Providence Regional Cancer System-Centralia
Centralia, Washington, United States, 98531
Swedish Medical Center-Edmonds
Edmonds, Washington, United States, 98026
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Providence Regional Cancer System-Lacey
Lacey, Washington, United States, 98503
PeaceHealth Saint John Medical Center
Longview, Washington, United States, 98632
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States, 98107
Kaiser Permanente Washington
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States, 98122-5711
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States, 98284
Providence Regional Cancer System-Shelton
Shelton, Washington, United States, 98584
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, United States, 99216
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States, 99204
Rockwood North Cancer Treatment Center
Spokane, Washington, United States, 99218
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Providence Regional Cancer System-Yelm
Yelm, Washington, United States, 98597
United States, Wisconsin
Ashland Memorial Medical Center
Ashland, Wisconsin, United States, 54806
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States, 53105
Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin, United States, 54937
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States, 53142
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States, 54143
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora Cancer Care-Racine
Racine, Wisconsin, United States, 53406
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States, 54241
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
United States, Wyoming
Big Horn Basin Cancer Center
Cody, Wyoming, United States, 82414
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Biologics, Inc.
Investigators
Layout table for investigator information
Study Chair: Anuj Mahindra, MD Scripps Health

Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02516423     History of Changes
Other Study ID Numbers: A061402
NCI-2015-00323 ( Registry Identifier: NCI Clinical Trials Reporting Program )
U10CA180821 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Plasmacytoma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Lenalidomide
Ixazomib
BB 1101
Zoledronic Acid
Glycine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Angiogenesis Inhibitors