Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial

Sponsor
ECOG-ACRIN Cancer Research Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT04566328
Collaborator
National Cancer Institute (NCI) (NIH)
1,450
460
3
86.1
3.2
0

Study Details

Study Description

Brief Summary

This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine if bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab and lenalidomide (DR) maintenance after standard induction therapy with daratumumab, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in minimal residual disease (MRD) positive patients.
SECONDARY OBJECTIVES:
  1. To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior overall survival compared to DRd consolidation followed by DR maintenance in MRD negative patients.

  2. To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior progression-free survival compared to DRd consolidation followed by DR maintenance in both MRD positive and MRD negative patients.

  3. To describe and compare the incidence of toxicities during consolidation between Btz-DRd and DRd arms.

  4. To assess the improvement in MRD negative rate with consolidation among patients who are MRD positive after induction.

  5. To assess the sustained MRD negative rate among patients who are MRD negative after induction.

PATIENT REPORTED OUTCOMES (PRO) OBJECTIVES:
  1. To quantify the extent to which the addition of bortezomib to DRd over consolidation treatment contributes to neuropathy and associated physical and functional impairments. (Primary PRO Objective) II. To evaluate the rate of resolution of neurotoxicity and associated physical and functional impairments following completion of consolidation therapy. (Secondary PRO Objective) III. To investigate the relationship between MRD status and patient reported health-related quality of life outcomes. (Exploratory PRO Objective) IV. To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events (PRO- Common Terminology Criteria for Adverse Events [CTCAE]) longitudinally and compare responses with provider-reported adverse events. (Exploratory PRO Objective) V. To tabulate PRO compliance and completion rates. (Exploratory PRO Objective)
IMAGING OBJECTIVES:
  1. To evaluate the association between post-induction fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) and patient outcomes (overall survival [OS] and progression-free survival [PFS]). (Primary Imaging Objective) II. To evaluate the association between baseline 18F-FDG PET/CT and patient outcomes (PFS and OS). (Secondary Imaging Objective) III. To compare overall survival with the addition of Bortezomib to consolidation DRd therapy among 18F-FDG PET/CT-positive and 18F-FDG PET/CT-negative subgroups. (Secondary Imaging Objective) IV. To evaluate the ability of baseline 18F-FDG PET/CT to predict post-induction depth of response as measured by MRD assessment. (Secondary Imaging Objective) V. To evaluate the ability of post-induction 18F-FDG PET/CT to predict MRD conversion post-consolidation. (Secondary Imaging Objective) VI. To utilize 18F-FDG PET/CT, standard risk factors and clinical data to identify distinct subgroups with differing patient outcomes (PFS and OS). (Exploratory Imaging Objective) VII. To compare the various qualitative 18F-FDG PET/CT criteria to determine which criteria yields superior risk stratification. (Exploratory Imaging Objective)
OUTLINE:
ARM A (INDUCTION): All patients receive standard induction therapy comprising the following:

daratumumab subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide orally (PO) daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

After completion of standard induction therapy, patients are randomized to 1 of 2 arms.

ARM B:

CONSOLIDATION: Patients receive bortezomib SC on days 1, 8, and 15, daratumumab SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21 and daratumumab SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM C:

CONSOLIDATION: Patients receive daratumumab SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21, and daratumumab SC on day

  1. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, every 6 months if 2-5 years from study entry, then annually for up to 15 years from study entry.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1450 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
Actual Study Start Date :
Oct 27, 2020
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A (daratumumab, lenalidomide, dexamethasone)

INDUCTION: All patients receive standard induction therapy comprising the following: daratumumab subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide orally (PO) daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

Biological: Daratumumab and Hyaluronidase-fihj
Given SC
Other Names:
  • DARA Co-formulated with rHuPH20
  • DARA/rHuPH20
  • Daratumumab + rHuPH20
  • Daratumumab with rHuPH20
  • Daratumumab-rHuPH20
  • Daratumumab/Hyaluronidase-fihj
  • Daratumumab/rHuPH20 Co-formulation
  • Darzalex Faspro
  • Darzalex/rHuPH20
  • HuMax-CD38-rHuPH20
  • Recombinant Human Hyaluronidase Mixed with Daratumumab
  • Drug: Dexamethasone
    Given PO
    Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
  • Drug: Lenalidomide
    Given PO
    Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Experimental: Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone)

    CONSOLIDATION: Patients receive bortezomib SC on days 1, 8, and 15, daratumumab SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21 and daratumumab SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Drug: Bortezomib
    Given SC
    Other Names:
  • [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
  • LDP 341
  • MLN341
  • PS-341
  • PS341
  • Velcade
  • Biological: Daratumumab and Hyaluronidase-fihj
    Given SC
    Other Names:
  • DARA Co-formulated with rHuPH20
  • DARA/rHuPH20
  • Daratumumab + rHuPH20
  • Daratumumab with rHuPH20
  • Daratumumab-rHuPH20
  • Daratumumab/Hyaluronidase-fihj
  • Daratumumab/rHuPH20 Co-formulation
  • Darzalex Faspro
  • Darzalex/rHuPH20
  • HuMax-CD38-rHuPH20
  • Recombinant Human Hyaluronidase Mixed with Daratumumab
  • Drug: Dexamethasone
    Given PO
    Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
  • Drug: Lenalidomide
    Given PO
    Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Active Comparator: Arm C (daratumumab, lenalidomide, dexamethasone)

    CONSOLIDATION: Patients receive daratumumab SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21, and daratumumab SC on day 1. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity.

    Biological: Daratumumab and Hyaluronidase-fihj
    Given SC
    Other Names:
  • DARA Co-formulated with rHuPH20
  • DARA/rHuPH20
  • Daratumumab + rHuPH20
  • Daratumumab with rHuPH20
  • Daratumumab-rHuPH20
  • Daratumumab/Hyaluronidase-fihj
  • Daratumumab/rHuPH20 Co-formulation
  • Darzalex Faspro
  • Darzalex/rHuPH20
  • HuMax-CD38-rHuPH20
  • Recombinant Human Hyaluronidase Mixed with Daratumumab
  • Drug: Dexamethasone
    Given PO
    Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
  • Drug: Lenalidomide
    Given PO
    Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Outcome Measures

    Primary Outcome Measures

    1. Consolidation overall survival [Time from Step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years]

      Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone [Btz-DRd] then daratumumab, lenalidomide and dexamethasone [DRd] then daratumumab and lenalidomide [DR]).

    Secondary Outcome Measures

    1. Consolidation progression-free survival [Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years]

      Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events.

    2. Incidence of adverse events [During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).]

    3. Incidence of grade 3 or higher non-hematologic adverse events [During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).]

    4. Incidence of grade 3 or higher adverse events [During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).]

    5. Best response [During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).]

    6. FACT-Ntx TOI recovery rate (Patient reported outcome [PRO]) [From end of induction through consolidation up to 1 year of maintenance, up to 21 weeks]

      Defined as the proportion of patients with the FACT-Ntx TOI score returning to baseline level reached at consolidation randomization after experiencing a MID decrease while on up to 1 year of maintenance.

    Other Outcome Measures

    1. Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome) [From end of induction to after completion of 9 cycles of consolidation, a period of approximately 36 weeks (9 months)]

      Calculated as the difference after completion of 9 cycles of consolidation therapy from end of induction. Scores can range from a minimum of 0 and a maximum of 44. A higher score on this assessment means a worse outcome.

    2. Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO) [From the end of induction through 1 year of maintenance, 21 weeks]

      The FACT-G is a single outcome measure made up of the PWB and FWB components. Scores range from a minimum of 0 and a maximum of 56. For this assessment, a higher score means a better outcome.

    3. Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO) [Up to 15 years]

      Presence, frequency, interference, amount and/or severity of select PRO-CTCAEs tabulated at each measurement.

    4. Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO) [Up to 15 years]

    5. PRO compliance rate [Up to 15 years]

      Defined as the proportion of patients who submit the given PRO instrument among those eligible at each time point which excludes those missing by design (due to death or disease progression, early treatment discontinuation).

    6. PRO completion rate [Up to 15 years]

      Defined as the proportion of patients who complete given PRO instrument based on the instrument's scoring system among those eligible at each time point.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • STEP 0 - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)

    • STEP 0 - Patient must have newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria

    • STEP 0 - Patient must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of RevREMS

    • STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.

    • NOTE: Bone marrow aspirate specimen must be submitted to Adaptive Biotechnologies for clonoSEQ Assay

    • NOTE: Adaptive Biotechnologies will release results to the diagnostic Portal from the Clonality (ID) test within fourteen (14) days of receipt and reconciliation of fresh bone marrow specimen to the submitting institution

    • STEP 1 - Patient must meet all eligibility criteria in STEP 0 with exception of allergy requirement

    • STEP 1 - Institution must have received the Clonality (ID) test results from Adaptive Biotechnologies and dominant sequences were identified

    • STEP 1 - Patient must have standard risk MM as defined by the Revised International Staging System (RISS) stage I or II

    • NOTE: R-ISS stage is based on serum beta2 microglobulin, albumin and lactate dehydrogenase (LDH) levels along with presence of chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization (iFISH). Presence of del(17p), t(4;14), and/or t(14;16) is considered high risk and absence of these, including any other findings, are standard risk

    • R-ISS stage

    • Stage I: ISS stage I [beta2 macroglobulin < 3.5 mg/L, albumin > 3.5 g/dL] AND standard-risk CA AND normal LDH

    • Stage II: Not R-ISS stage I or III

    • Stage III: ISS stage III [beta2 macroglobulin > 5.5 mg/L] AND high-risk CA OR high LDH (> upper limit of normal) [patients with stage III are ineligible]

    • STEP 1 - Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to registration:

    • = 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis

    • = 200 mg/24 hours of monoclonal protein on a 24-hour urine protein electrophoresis

    • Involved free light chain >= 10 mg/dL or >= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65)

    • Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)

    • STEP 1 - Patients must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response

    • NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr. Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response

    • NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine. Measurable disease in the serum is defined as having a serum M-spike >= 1 g/dL. Measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr

    • STEP 1 - Calculated creatinine clearance > 30 mL/min (obtained =< 14 days prior to Step 1 registration)

    • STEP 1 - Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 14 days prior to Step 1 registration)

    • STEP 1 - Untransfused platelet count >= 75,000/mm^3 (obtained =< 14 days prior to Step 1 registration)

    • STEP 1 - Hemoglobin >= 8.0 g/dL (obtained =< 14 days prior to Step 1 registration)

    • STEP 1 - Total bilirubin =< 1.5 x ULN (institutional upper limit of normal) (obtained =< 14 days prior to Step 1 registration)

    • STEP 1 - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (obtained =< 14 days prior to Step 1 registration)

    • STEP 1 - Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Patient must not have been exposed to daratumumab for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there are no residual toxicity related to radiation and blood counts meet the study requirements. Radiation treatment must be completed at least 14 days prior to Step 1 registration

    • STEP 1 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial

    • STEP 1 - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

    • STEP 1 - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

    • STEP 1 - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

    • STEP 1 - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients must not have evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within 6 months prior to Step 1 registration

    • STEP 1 - Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation

    • STEP 1 - Patients with a history of chronic obstructive pulmonary disease (COPD) must have FEV1 testing done within 28 days prior to Step 1 registration and the forced expiratory volume in 1 second (FEV1) must be > 50% of predicted normal

    • STEP 2 - Institution must have received Tracking (MRD) test results from Adaptive Biotechnologies

    • STEP 2 - Patient must have completed the Step 1 Induction phase of this protocol without experiencing progression

    • STEP 2 - Patient must be registered to Step 2 within 8 weeks of completing Step 1 Induction Treatment, counting from last day of completion of last cycle

    • STEP 2 - Patient must have an ECOG performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)

    • STEP 2 - Any adverse event(s) related to Step 1 Induction Treatment must have resolved to grade 2 or less

    • STEP 2 - Hemoglobin >= 8 g/dL (obtained within 14 days prior to Step 2 randomization)

    • STEP 2 - Platelet count >= 50,000/mm^3 (obtained within 14 days prior to Step 2 randomization)

    • STEP 2 - Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained within 14 days prior to Step 2 randomization)

    • STEP 2 - Calculated creatinine clearance >= 30 mL/min (obtained within 14 days prior to Step 2 randomization)

    • STEP 2 - Total bilirubin =< 1.5 x ULN (Institutional upper limit of normal) (obtained within 14 days prior to Step 2 randomization)

    • STEP 2 - ALT and AST < 3 x ULN (obtained within 14 days prior to Step 2 randomization)

    Exclusion Criteria:
    • STEP 0 - Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products

    • STEP 1 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 1 registration to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:

    • Has achieved menarche at some point,

    • Has not undergone a hysterectomy or bilateral oophorectomy; or

    • Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

    • STEP 1 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment

    • STEP 1 - Patient must not have peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain at time of Step 1 registration

    • STEP 1 - Patient must not have any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol

    • STEP 1 - Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification

    • NOTE: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to register

    • STEP 1 - Patient must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol

    • NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment

    • STEP 2 - Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant

    • STEP 2 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 2 randomization to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:

    • Has achieved menarche at some point,

    • Has not undergone a hysterectomy or bilateral oophorectomy; or

    • Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

    • STEP 2 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).

    Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    2 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
    3 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
    4 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
    5 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    6 Anchorage Oncology Centre Anchorage Alaska United States 99508
    7 Katmai Oncology Group Anchorage Alaska United States 99508
    8 Providence Alaska Medical Center Anchorage Alaska United States 99508
    9 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
    10 University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona United States 85704
    11 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    12 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    13 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
    14 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    15 Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California United States 93420
    16 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    17 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
    18 Mission Hope Medical Oncology - Santa Maria Santa Maria California United States 93444
    19 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    20 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    21 Saint Francis Cancer Center Colorado Springs Colorado United States 80923
    22 Porter Adventist Hospital Denver Colorado United States 80210
    23 Mercy Medical Center Durango Colorado United States 81301
    24 Southwest Oncology PC Durango Colorado United States 81301
    25 Saint Anthony Hospital Lakewood Colorado United States 80228
    26 Littleton Adventist Hospital Littleton Colorado United States 80122
    27 Longmont United Hospital Longmont Colorado United States 80501
    28 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
    29 Parker Adventist Hospital Parker Colorado United States 80138
    30 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    31 Smilow Cancer Hospital-Derby Care Center Derby Connecticut United States 06418
    32 Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut United States 06824
    33 Smilow Cancer Hospital Care Center at Glastonbury Glastonbury Connecticut United States 06033
    34 Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut United States 06830
    35 Smilow Cancer Hospital Care Center - Guiford Guilford Connecticut United States 06437
    36 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    37 Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut United States 06510
    38 Yale University New Haven Connecticut United States 06520
    39 Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut United States 06473
    40 Smilow Cancer Hospital-Orange Care Center Orange Connecticut United States 06477
    41 Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut United States 06790
    42 Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut United States 06611
    43 Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut United States 06708
    44 Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut United States 06385
    45 Beebe South Coastal Health Campus Frankford Delaware United States 19945
    46 Beebe Medical Center Lewes Delaware United States 19958
    47 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
    48 Helen F Graham Cancer Center Newark Delaware United States 19713
    49 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    50 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    51 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    52 TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware United States 19973
    53 Christiana Care Health System-Wilmington Hospital Wilmington Delaware United States 19801
    54 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    55 Sacred Heart Hospital Pensacola Florida United States 32504
    56 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    57 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    58 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    59 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
    60 Walter Knox Memorial Hospital Emmett Idaho United States 83617
    61 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    62 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    63 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    64 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    65 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    66 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    67 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
    68 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    69 Saint Anthony's Health Alton Illinois United States 62002
    70 Rush - Copley Medical Center Aurora Illinois United States 60504
    71 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    72 Loyola Center for Health at Burr Ridge Burr Ridge Illinois United States 60527
    73 Illinois CancerCare-Canton Canton Illinois United States 61520
    74 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    75 SIH Cancer Institute Carterville Illinois United States 62918
    76 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    77 Centralia Oncology Clinic Centralia Illinois United States 62801
    78 University of Illinois Chicago Illinois United States 60612
    79 Carle on Vermilion Danville Illinois United States 61832
    80 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    81 Decatur Memorial Hospital Decatur Illinois United States 62526
    82 Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois United States 60115
    83 Illinois CancerCare-Dixon Dixon Illinois United States 61021
    84 Carle Physician Group-Effingham Effingham Illinois United States 62401
    85 Crossroads Cancer Center Effingham Illinois United States 62401
    86 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    87 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    88 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    89 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    90 Loyola Medicine Homer Glen Homer Glen Illinois United States 60491
    91 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    92 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    93 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    94 Loyola University Medical Center Maywood Illinois United States 60153
    95 Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park Illinois United States 60160
    96 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    97 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    98 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    99 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    100 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    101 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    102 Illinois CancerCare-Peru Peru Illinois United States 61354
    103 Valley Radiation Oncology Peru Illinois United States 61354
    104 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    105 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    106 Springfield Clinic Springfield Illinois United States 62702
    107 Memorial Medical Center Springfield Illinois United States 62781
    108 Carle Cancer Center Urbana Illinois United States 61801
    109 The Carle Foundation Hospital Urbana Illinois United States 61801
    110 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    111 Illinois CancerCare - Washington Washington Illinois United States 61571
    112 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
    113 IU Health North Hospital Carmel Indiana United States 46032
    114 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    115 IU Health Methodist Hospital Indianapolis Indiana United States 46202
    116 Reid Health Richmond Indiana United States 47374
    117 Mary Greeley Medical Center Ames Iowa United States 50010
    118 McFarland Clinic PC - Ames Ames Iowa United States 50010
    119 McFarland Clinic PC-Boone Boone Iowa United States 50036
    120 Saint Anthony Regional Hospital Carroll Iowa United States 51401
    121 Mercy Hospital Cedar Rapids Iowa United States 52403
    122 Oncology Associates at Mercy Medical Center Cedar Rapids Iowa United States 52403
    123 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    124 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    125 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
    126 Greater Regional Medical Center Creston Iowa United States 50801
    127 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    128 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    129 Broadlawns Medical Center Des Moines Iowa United States 50314
    130 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    131 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    132 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    133 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
    134 Trinity Regional Medical Center Fort Dodge Iowa United States 50501
    135 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
    136 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
    137 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    138 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    139 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    140 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    141 Flaget Memorial Hospital Bardstown Kentucky United States 40004
    142 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
    143 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    144 Saint Joseph Hospital East Lexington Kentucky United States 40509
    145 Saint Joseph London London Kentucky United States 40741
    146 Jewish Hospital Louisville Kentucky United States 40202
    147 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
    148 Jewish Hospital Medical Center Northeast Louisville Kentucky United States 40245
    149 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
    150 Ochsner LSU Health Monroe Medical Center Monroe Louisiana United States 71202
    151 LSU Health Sciences Center at Shreveport Shreveport Louisiana United States 71103
    152 Frederick Memorial Hospital Frederick Maryland United States 21701
    153 FMH James M Stockman Cancer Institute Frederick Maryland United States 21702
    154 Tufts Medical Center Boston Massachusetts United States 02111
    155 Hickman Cancer Center Adrian Michigan United States 49221
    156 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    157 Bronson Battle Creek Battle Creek Michigan United States 49017
    158 IHA Hematology Oncology Consultants-Brighton Brighton Michigan United States 48114
    159 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    160 IHA Hematology Oncology Consultants-Canton Canton Michigan United States 48188
    161 Saint Joseph Mercy Canton Canton Michigan United States 48188
    162 Caro Cancer Center Caro Michigan United States 48723
    163 IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan United States 48118
    164 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    165 Hematology Oncology Consultants-Clarkston Clarkston Michigan United States 48346
    166 Newland Medical Associates-Clarkston Clarkston Michigan United States 48346
    167 Ascension Saint John Hospital Detroit Michigan United States 48236
    168 Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan United States 48054
    169 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
    170 Genesee Hematology Oncology PC Flint Michigan United States 48503
    171 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    172 Hurley Medical Center Flint Michigan United States 48503
    173 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    174 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    175 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    176 Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan United States 48236
    177 Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan United States 48236
    178 Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan United States 48236
    179 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    180 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    181 Ascension Borgess Cancer Center Kalamazoo Michigan United States 49009
    182 Borgess Medical Center Kalamazoo Michigan United States 49048
    183 Sparrow Hospital Lansing Michigan United States 48912
    184 Hope Cancer Clinic Livonia Michigan United States 48154
    185 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    186 Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan United States 48044
    187 Michigan Breast Specialists-Macomb Township Macomb Michigan United States 48044
    188 Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan United States 48453
    189 Toledo Clinic Cancer Centers-Monroe Monroe Michigan United States 48162
    190 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    191 Lakeland Hospital Niles Niles Michigan United States 49120
    192 Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan United States 49444
    193 Ascension Providence Hospitals - Novi Novi Michigan United States 48374
    194 21st Century Oncology-Pontiac Pontiac Michigan United States 48341
    195 Hope Cancer Center Pontiac Michigan United States 48341
    196 Newland Medical Associates-Pontiac Pontiac Michigan United States 48341
    197 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    198 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    199 Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan United States 48309
    200 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    201 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
    202 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    203 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    204 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    205 Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan United States 48312
    206 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
    207 Munson Medical Center Traverse City Michigan United States 49684
    208 Advanced Breast Care Center PLLC Warren Michigan United States 48088
    209 Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan United States 48093
    210 Macomb Hematology Oncology PC Warren Michigan United States 48093
    211 Michigan Breast Specialists-Warren Warren Michigan United States 48093
    212 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    213 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
    214 Metro Health Hospital Wyoming Michigan United States 49519
    215 Huron Gastroenterology PC Ypsilanti Michigan United States 48106
    216 IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan United States 48197
    217 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    218 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    219 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
    220 Cambridge Medical Center Cambridge Minnesota United States 55008
    221 Mercy Hospital Coon Rapids Minnesota United States 55433
    222 Fairview Southdale Hospital Edina Minnesota United States 55435
    223 Unity Hospital Fridley Minnesota United States 55432
    224 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    225 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    226 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    227 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    228 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    229 Health Partners Inc Minneapolis Minnesota United States 55454
    230 Monticello Cancer Center Monticello Minnesota United States 55362
    231 New Ulm Medical Center New Ulm Minnesota United States 56073
    232 Fairview Northland Medical Center Princeton Minnesota United States 55371
    233 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    234 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    235 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    236 Regions Hospital Saint Paul Minnesota United States 55101
    237 United Hospital Saint Paul Minnesota United States 55102
    238 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    239 Lakeview Hospital Stillwater Minnesota United States 55082
    240 Sanford Thief River Falls Medical Center Thief River Falls Minnesota United States 56701
    241 Ridgeview Medical Center Waconia Minnesota United States 55387
    242 Rice Memorial Hospital Willmar Minnesota United States 56201
    243 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    244 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    245 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    246 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    247 Cox Cancer Center Branson Branson Missouri United States 65616
    248 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    249 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    250 Parkland Health Center - Farmington Farmington Missouri United States 63640
    251 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    252 Freeman Health System Joplin Missouri United States 64804
    253 Mercy Hospital Joplin Joplin Missouri United States 64804
    254 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    255 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    256 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    257 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    258 Mercy Hospital South Saint Louis Missouri United States 63128
    259 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    260 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    261 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    262 Mercy Hospital Springfield Springfield Missouri United States 65804
    263 CoxHealth South Hospital Springfield Missouri United States 65807
    264 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    265 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    266 Mercy Hospital Washington Washington Missouri United States 63090
    267 Community Hospital of Anaconda Anaconda Montana United States 59711
    268 Billings Clinic Cancer Center Billings Montana United States 59101
    269 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    270 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    271 Great Falls Clinic Great Falls Montana United States 59405
    272 Kalispell Regional Medical Center Kalispell Montana United States 59901
    273 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    274 Community Medical Hospital Missoula Montana United States 59804
    275 CHI Health Saint Francis Grand Island Nebraska United States 68803
    276 CHI Health Good Samaritan Kearney Nebraska United States 68847
    277 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
    278 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    279 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    280 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    281 Creighton University Medical Center Omaha Nebraska United States 68131
    282 Midlands Community Hospital Papillion Nebraska United States 68046
    283 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    284 Glens Falls Hospital Glens Falls New York United States 12801
    285 Stony Brook University Medical Center Stony Brook New York United States 11794
    286 Good Samaritan Hospital Medical Center West Islip New York United States 11795
    287 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    288 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    289 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    290 Vidant Oncology-Kenansville Kenansville North Carolina United States 28349
    291 Vidant Oncology-Kinston Kinston North Carolina United States 28501
    292 Vidant Oncology-Richlands Richlands North Carolina United States 28574
    293 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    294 Sanford South University Medical Center Fargo North Dakota United States 58103
    295 Southpointe-Sanford Medical Center Fargo Fargo North Dakota United States 58103
    296 Sanford Medical Center Fargo Fargo North Dakota United States 58104
    297 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    298 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    299 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
    300 Indu and Raj Soin Medical Center Beavercreek Ohio United States 45431
    301 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    302 Saint Elizabeth Boardman Hospital Boardman Ohio United States 44512
    303 Dayton Physicians LLC-Miami Valley South Centerville Ohio United States 45459
    304 Miami Valley Hospital South Centerville Ohio United States 45459
    305 Geauga Hospital Chardon Ohio United States 44024
    306 Adena Regional Medical Center Chillicothe Ohio United States 45601
    307 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    308 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    309 Oncology Hematology Care Inc-Kenwood Cincinnati Ohio United States 45236
    310 Bethesda North Hospital Cincinnati Ohio United States 45242
    311 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
    312 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
    313 Case Western Reserve University Cleveland Ohio United States 44106
    314 Mount Carmel East Hospital Columbus Ohio United States 43213
    315 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    316 Riverside Methodist Hospital Columbus Ohio United States 43214
    317 Grant Medical Center Columbus Ohio United States 43215
    318 The Mark H Zangmeister Center Columbus Ohio United States 43219
    319 Mount Carmel Health Center West Columbus Ohio United States 43222
    320 Doctors Hospital Columbus Ohio United States 43228
    321 Miami Valley Hospital Dayton Ohio United States 45409
    322 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
    323 Miami Valley Hospital North Dayton Ohio United States 45415
    324 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
    325 Grady Memorial Hospital Delaware Ohio United States 43015
    326 Dublin Methodist Hospital Dublin Ohio United States 43016
    327 Armes Family Cancer Center Findlay Ohio United States 45840
    328 Blanchard Valley Hospital Findlay Ohio United States 45840
    329 Orion Cancer Care Findlay Ohio United States 45840
    330 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    331 Dayton Physicians LLC-Atrium Franklin Ohio United States 45005
    332 Central Ohio Breast and Endocrine Surgery Gahanna Ohio United States 43230
    333 Dayton Physicians LLC-Wayne Greenville Ohio United States 45331
    334 Wayne Hospital Greenville Ohio United States 45331
    335 Mount Carmel Grove City Hospital Grove City Ohio United States 43123
    336 Greater Dayton Cancer Center Kettering Ohio United States 45409
    337 Kettering Medical Center Kettering Ohio United States 45429
    338 Fairfield Medical Center Lancaster Ohio United States 43130
    339 Saint Rita's Medical Center Lima Ohio United States 45801
    340 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    341 Marietta Memorial Hospital Marietta Ohio United States 45750
    342 OhioHealth Marion General Hospital Marion Ohio United States 43302
    343 UH Seidman Cancer Center at Landerbrook Health Center Mayfield Heights Ohio United States 44124
    344 Knox Community Hospital Mount Vernon Ohio United States 43050
    345 Licking Memorial Hospital Newark Ohio United States 43055
    346 Newark Radiation Oncology Newark Ohio United States 43055
    347 Mercy Health Perrysburg Cancer Center Perrysburg Ohio United States 43551
    348 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    349 Springfield Regional Cancer Center Springfield Ohio United States 45504
    350 Springfield Regional Medical Center Springfield Ohio United States 45505
    351 Saint Vincent Mercy Medical Center Toledo Ohio United States 43608
    352 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    353 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    354 Dayton Physicians LLC-Upper Valley Troy Ohio United States 45373
    355 Upper Valley Medical Center Troy Ohio United States 45373
    356 University Hospitals Sharon Health Center Wadsworth Ohio United States 44281
    357 Saint Joseph Warren Hospital Warren Ohio United States 44484
    358 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    359 Saint Ann's Hospital Westerville Ohio United States 43081
    360 UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio United States 44145
    361 Saint Elizabeth Youngstown Hospital Youngstown Ohio United States 44501
    362 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    363 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    364 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
    365 Saint Charles Health System Bend Oregon United States 97701
    366 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    367 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
    368 Bay Area Hospital Coos Bay Oregon United States 97420
    369 Providence Newberg Medical Center Newberg Oregon United States 97132
    370 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    371 Providence Portland Medical Center Portland Oregon United States 97213
    372 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    373 Oregon Health and Science University Portland Oregon United States 97239
    374 Saint Charles Health System-Redmond Redmond Oregon United States 97756
    375 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    376 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    377 Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania United States 19317
    378 Pocono Medical Center East Stroudsburg Pennsylvania United States 18301
    379 Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania United States 18201
    380 Reading Hospital West Reading Pennsylvania United States 19611
    381 Smilow Cancer Hospital Care Center - Westerly Westerly Rhode Island United States 02891
    382 Ralph H Johnson VA Medical Center Charleston South Carolina United States 29401
    383 Medical University of South Carolina Charleston South Carolina United States 29425
    384 Saint Francis Hospital Greenville South Carolina United States 29601
    385 Saint Francis Cancer Center Greenville South Carolina United States 29607
    386 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    387 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
    388 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    389 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    390 Centra Lynchburg Hematology-Oncology Clinic Inc Lynchburg Virginia United States 24501
    391 Virginia Cancer Institute Richmond Virginia United States 23230
    392 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    393 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    394 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    395 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    396 Harrison Medical Center Bremerton Washington United States 98310
    397 Highline Medical Center-Main Campus Burien Washington United States 98166
    398 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    399 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
    400 Saint Elizabeth Hospital Enumclaw Washington United States 98022
    401 Providence Regional Cancer Partnership Everett Washington United States 98201
    402 Saint Francis Hospital Federal Way Washington United States 98003
    403 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    404 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    405 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    406 Saint Clare Hospital Lakewood Washington United States 98499
    407 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    408 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
    409 Pacific Gynecology Specialists Seattle Washington United States 98104
    410 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    411 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    412 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122-5711
    413 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    414 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
    415 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
    416 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
    417 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    418 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    419 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
    420 ThedaCare Regional Cancer Center Appleton Wisconsin United States 54911
    421 SSM Health Dean Medical Group - Baraboo Baraboo Wisconsin United States 53913
    422 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    423 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
    424 Aurora Saint Luke's South Shore Cudahy Wisconsin United States 53110
    425 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    426 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    427 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    428 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    429 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    430 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    431 Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin United States 54601
    432 Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin United States 54848
    433 William S Middleton VA Medical Center Madison Wisconsin United States 53705
    434 Dean Hematology and Oncology Clinic Madison Wisconsin United States 53717
    435 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    436 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    437 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    438 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    439 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    440 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    441 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    442 ProHealth D N Greenwald Center Mukwonago Wisconsin United States 53149
    443 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    444 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    445 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    446 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    447 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    448 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    449 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    450 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    451 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    452 ProHealth Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    453 UW Cancer Center at ProHealth Care Waukesha Wisconsin United States 53188
    454 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    455 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    456 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    457 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    458 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    459 Billings Clinic-Cody Cody Wyoming United States 82414
    460 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • ECOG-ACRIN Cancer Research Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Shaji K Kumar, ECOG-ACRIN Cancer Research Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ECOG-ACRIN Cancer Research Group
    ClinicalTrials.gov Identifier:
    NCT04566328
    Other Study ID Numbers:
    • EAA181
    • NCI-2020-06647
    • EAA181
    • EAA181
    • U10CA180820
    First Posted:
    Sep 28, 2020
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2021