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S1803, Daratumumab/rHuPh20 +/- Lenalidomide as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration (DRAMMATIC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04071457
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Janssen, LP
Adaptive
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Drug: Daratumumab/rHuPH20 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: S1803, Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients With Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : July 1, 2029
Estimated Study Completion Date : July 1, 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
No Intervention: Study Entry / Screening
Study entry/screening to follow patient until Maintenance.
Active Comparator: Arm 1: Lenalidomide
Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 2 years from starting treatment.
Drug: Lenalidomide
Commercially available intervention
Other Names:
  • CC-5013
  • Revlimid

Experimental: Arm 2: Lenalidomide + Daratumumab/rHuPH20
Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 2 years from starting treatment. Plus Daratumumab/rHuPH20 1800 mg/30,000 units D1, 8, 15, 22 q 28 days for 2 cycles, then D 1 and 15 q 28 days for cycles 3-6 then D1 q 28 days for subsequent cycles for up to 2 years from starting treatment.
Drug: Lenalidomide
Commercially available intervention
Other Names:
  • CC-5013
  • Revlimid

Drug: Daratumumab/rHuPH20
SWOG-Held IND

Active Comparator: Arm 1a: Continue Lenalidomide
MRD+ or MRD- and randomized to Arm 1a: Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 7 years from starting treatment.
Drug: Lenalidomide
Commercially available intervention
Other Names:
  • CC-5013
  • Revlimid

No Intervention: Arm 1b: Stop Lenalidomide
MRD- and randomized to Arm 1b: Discontinue protocol therapy.
Active Comparator: Arm 2a: Continue Lenalidomide + Daratumumab/rHuPH20
MRD+ or MRD- and randomized to Arm 2a: Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 7 years from starting treatment. Plus Daratumumab/rHuPH20 1800 mg/30,000 units D1, 8, 15, 22 q 28 days for 2 cycles, then D 1 and 15 q 28 days for cycles 3-6 then D1 q 28 days for subsequent cycles for up to 7 years from starting treatment.
Drug: Lenalidomide
Commercially available intervention
Other Names:
  • CC-5013
  • Revlimid

Drug: Daratumumab/rHuPH20
SWOG-Held IND

No Intervention: Arm 2b: Stop Lenalidomide + Daratumumab/rHuPH20
MRD- and randomized to Arm 2b: Discontinue protocol therapy.



Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of intial randomization until death due to any cause, assessed up to 15 years ]
    Overall survival will evaluated using a weighted log-rank test and will be compared between primary treatment arms. All eligible patients with valid consent will be included in the analysis. Patients last known to be alive are censored at the date of last contact.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: From date of intial randomization until progression or death due to any cause, whichever occurs first, assessed up to 7 years ]
    Progression-free survival will evaluated using a weighted log-rank test and will be compared between primary treatment arms. All eligible patients with valid consent will be included in the analysis. Patients last known to be progression-free and alive are censored at the date of last contact.

  2. Response (PR or better) [ Time Frame: From date of initial randomization until date of best response while on study treatment. ]
    Per International Uniform Response Criteria for Multiple Myeloma PR- ≥ 50% reduction in size of soft tissue plasmacytomas & plasma cells; ≥ 50% decrease in serum & reduction in urine M protein ≥ 90% or to < 200 mg/24hr or ≥ 50% decrease in difference in uninvolved & involved serum free light chain levels; VGPR- PR + Serum and urine M proteins detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M protein & urine M protein < 100 mg/24 hrs; uPR- 1 objective status of PR, but confirmation studies are not done, or do not meet the requirements necessary to confirm response; SD- does not meet criteria for sCR, CR, VGPR, PR or PROG; PROG- new or increase in size of existing bone lesions or soft tissue plasmacytomas/ development of hypercalcemia attributable solely to MM/ ≥ 25% increase from baseline/ lowest response level of either serum or Urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage.

  3. MRD Negativity [ Time Frame: 24 months from initial randomization ]

    The rate of MRD response will be calculated as the number of patients who achieved MRD response divided by the number of eligible patients; patients without a conclusive MRD results will be included as non-responders. Comparisons between arms will be made using a stratified Cochran-Mantel-Haenszel test.

    MRD data will be collected from the central testing laboratory, including percent of cells detected and total cells collected. Unless the sample is limiting, 5 x 106 events are collected for a standard multiple myeloma MRD sensitivities of 0.0001%.

    MRD negativity will be defined as no templates observed at a sensitivity of 1 in a million cells assessed, with a minimum of 1 million cells being assessed.

    MRD positivity will be defined as any templates observed regardless of the number of cells analyzed, or non-diagnostic specimens, including if the reference specimen from diagnosis is not able to be sequenced.



Other Outcome Measures:
  1. Toxicity assessment [ Time Frame: From the time of intial randomization for up to 7 years. ]
    All randomized patients that have initiated treatment will be considered evaluable for toxicity analyses. The maximum Grade for each toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.



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 to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Registration Step 1 Except where otherwise indicated below that test is required in a shorter timeframe, all tests for establishing baseline disease status must be completed within 60 days prior to registration. All test results must be documented on the Baseline Tumor Assessment Form for Multiple Myeloma and the Onstudy Form.

Inclusion Criteria

  • Patients must have had a confirmed diagnosis of symptomatic multiple myeloma (See Section 4.1) that required systemic induction therapy prior to autologous stem cell transplantation (ASCT).
  • Patients with disease measurable by serum light chain assay alone are eligible (defined as >/= 100 mg/L on involved light chain).
  • Patients must be registered to Step 1 prior to registration to Step 2. Registration to Step 1 may take place prior to or after autologous stem cell transplant (ASCT), but after completion of induction therapy.
  • Patients must have initiated induction therapy within 12 months prior to registration Step 1 and have received at least two cycles of induction therapy.
  • Patients must be willing and able to take DVT prophylaxis (aspirin, low molecular weight heparin, warfarin, or equivalent oral anticoagulation).
  • Patients must be >/= 18 and </= 75 years of age at time of registration to Step 1.
  • Patients must have history and physical exam within 28 days prior to registration.
  • Patients must have Zubrod Performance Status </= 2.
  • Patients must have evidence of adequate renal function, as defined by (1) creatinine clearance (CrCl) >/= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula, or (2) serum creatinine < 2.5 mg/dL. Values must be obtained within 28 days prior to registration.
  • Patients must have adequate hepatic function defined by the following within 42 days prior to registration:

    • Total bilirubin </=1.5 x IULN (institutional upper limit of the norm) AND
    • AST and ALT </=3.0 x IULN
  • Patients must meet one of the following criteria:

    • Be acceptable for transplant per institutional guidelines and the criteria evidencing this must be documented on the S1803 Onstudy Form. (See Appendix 18.3 for standard transplant eligibility guidelines. Note that these are guidelines and not required criteria.) OR
    • Have completed autologous stem cell transplant within 180 days prior to registration (see also Section 5.2a).
  • Patient's with human immunodeficiency virus (HIV) are eligible providing they are on effective antiretroviral therapy and have undetectable viral load at their most previous viral load test and within 6 months prior to registration.
  • Patients must be able to take and swallow oral medication (capsules) whole. Patients may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • For patients who have not yet received transplant: Patients must be willing and able to return to the transplant center for their assigned treatment after randomization. Note that patients need not have a direct relationship with the transplant center in order to register.
  • Patients must submit specimens for MRD as outlined in Section 15.1. See Section 15.1 for further information, including specimen submission timepoints. Note that patients are not ineligible based solely on archival specimens being unavailable.
  • Patients must be offered participation in specimen banking for future research. With patient's consent, specimens must be submitted as outlined in Section 15.2.
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • As a part of the OPEN registration process (see Section 13.3 for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Exclusion Criteria

  • Patients with smoldering myeloma are not eligible. Patients with purely non-secretory MM as measured by electrophoresis and immunofixation and the absence of Bence Jones proteins in the urine are not eligible. Patients must have measurable M protein in the serum (defined as >/= 0.5g/dL) or urine (defined as >/= 200 mg/24h). Patients with plasma cell leukemia are not eligible.
  • Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
  • Patients must not have progressive disease at any time prior to registration.
  • Patients must not be refractory to either lenalidomide or daratumumab/rHuPH20.
  • Patients must not be intolerant to either lenalidomide or daratumumab/rHuPH20.
  • Patients must not have received any investigational agents within 14 days prior to registration.
  • Patients must not have chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. FEV1 is required for patients suspected of having chronic obstructive pulmonary disease and are not eligible if FEV1 is < 50% of predicted normal.
  • Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
  • Patients must not have had prior autograft or allograft, or prior organ transplant requiring immunosuppressive therapy.
  • Patients must not have known allergy to any of the study drugs.
  • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment are not eligible.
  • Patients must not have known central nervous system (CNS) involvement with multiple myeloma, defined as CSF positivity for plasma cells at any time or a parenchymal CNS plasmacytoma at time of enrollment. Lumbar puncture is not required.
  • Patients must not be seropositive for hepatitis C (except in the setting of sustained virologic response, defined as undetectable viral load at least 12 weeks after completion of antiviral therapy). HCV testing is only required if clinically indicated or if the patient has a history of HCV.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
  • Patients must not have any uncontrolled intercurrent illness including (not limited to): Symptomatic CHF (NYHA III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration, Unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade >/= 2), intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>/= Grade 3), or known psychiatric illness that would limit study compliance.

Registration Step 2 - First Randomization (Post-ASCT, Pre-Maintenance)

Inclusion Criteria:

  • Patients must have completed ASCT within 180 days prior to registering to Step 2.
  • Patients must have one of the following performed within 60 days prior to registration for disease assessment: diagnostic quality skeletal survey, whole body CT scan, MRI, or PET.
  • Patients must have Zubrod Performance Status </= 2
  • Patients must have adequate bone marrow function as evidenced by platelets >/= 75,000/mm3 and ANC >/= 1,000/mm3 within 28 days prior to first randomization:
  • Patients must have adequate hepatic function defined by the following within 28 days prior to first randomization:
  • Total bilirubin </=1.5 x IULN (institutional upper limit of the norm) AND AST and ALT </=3.0 x IULN
  • Patients must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) >/= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula, or have a serum creatinine < 2.5 mg/dL within 28 days prior to first randomization.
  • All ASCT-related toxicities must have recovered to </=Grade 1 (except for alopecia, fatigue and amenorrhea) prior to first randomization.
  • Mucositis and gastrointestinal symptoms must have resolved to </=Grade 1.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration.
  • FCBP must agree to have a second pregnancy test within 24 hours prior to starting Cycle 1. Further, FCBP 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 starting lenalidomide. FCBP must also agree to ongoing pregnancy testing and must agree to not become pregnant for at least 3 months after the last dose of study treatment.
  • Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy, during the study treatment and for 3 months after the last dose of study treatment.
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  • Patients must not have received any other maintenance therapy post-ASCT and prior to Step 2 registration.
  • Patients must not have had progressive disease between induction and registration to Registration Step 2. (See Section 10.1b).

Registration Step 3 - Second Randomization (Post 24 Months Maintenance)

Inclusion Criteria:

  • Patients must have completed 24 cycles of protocol maintenance with either lenalidomide or lenalidomide + daratumumab/rHuPH20.
  • Patients must have 24-month MRD by NGS test results available and must be MRD negative. Patients whose PCR results are indeterminable will be considered to have positive results.
  • Patients must be in very good partial remission (VGPR) or better by IMWG response criteria (see Section 10.1b).

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): NCT04071457


Contacts
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Contact: Cynthia Smith, MBA 210-614-8808 csmith@swog.org
Contact: Dana Sparks, MAT 210-614-8808 dsparks@swog.org

  Hide Study Locations
Locations
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United States, Arkansas
Mercy Hospital Fort Smith Recruiting
Fort Smith, Arkansas, United States, 72903
Contact: Site Public Contact    800-378-9373      
Principal Investigator: Jay W. Carlson         
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Site Public Contact    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Amrita Y. Krishnan         
United States, Florida
UF Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Site Public Contact    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Daniel Landau         
United States, Illinois
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Loyola Center for Health at Burr Ridge Recruiting
Burr Ridge, Illinois, United States, 60527
Contact: Site Public Contact    708-216-9000      
Principal Investigator: Patrick A. Hagen         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Memorial Hospital of Carbondale Recruiting
Carbondale, Illinois, United States, 62902
Contact: Site Public Contact    618-457-5200    clinical.research@sih.net   
Principal Investigator: Bryan A. Faller         
SIH Cancer Institute Recruiting
Carterville, Illinois, United States, 62918
Contact: Site Public Contact    618-985-3333    clinical.research@sih.net   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Cancer Care Specialists of Illinois - Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Dixon Recruiting
Dixon, Illinois, United States, 61021
Contact: Site Public Contact    815-285-7800      
Principal Investigator: Bryan A. Faller         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Western Illinois Cancer Treatment Center Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-344-2831      
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Site Public Contact    708-226-4357      
Principal Investigator: Patrick A. Hagen         
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Recruiting
Melrose Park, Illinois, United States, 60160
Contact: Site Public Contact    708-450-4554      
Principal Investigator: Patrick A. Hagen         
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Site Public Contact    618-242-4600      
Principal Investigator: Jay W. Carlson         
Loyola Center for Cancer Care and Research Recruiting
Orland Park, Illinois, United States, 60462
Contact: Site Public Contact    708-216-9000      
Principal Investigator: Patrick A. Hagen         
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Valley Radiation Oncology Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    815-664-4141      
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Bryan A. Faller         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    800-444-7541      
Principal Investigator: Bryan A. Faller         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact    217-788-3528      
Principal Investigator: Bryan A. Faller         
Cancer Care Specialists of Illinois-Swansea Recruiting
Swansea, Illinois, United States, 62226
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Southwest Illinois Health Services LLP Recruiting
Swansea, Illinois, United States, 62226
Contact: Site Public Contact    618-236-1000    lynns@thecancercenter.com   
Principal Investigator: Bryan A. Faller         
United States, Iowa
Mary Greeley Medical Center Recruiting
Ames, Iowa, United States, 50010
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC - Ames Recruiting
Ames, Iowa, United States, 50010
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Boone Recruiting
Boone, Iowa, United States, 50036
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Trinity Cancer Center Recruiting
Fort Dodge, Iowa, United States, 50501
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Jefferson Recruiting
Jefferson, Iowa, United States, 50129
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
McFarland Clinic PC-Marshalltown Recruiting
Marshalltown, Iowa, United States, 50158
Contact: Site Public Contact    515-956-4132      
Principal Investigator: Debra M. Prow         
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Cambridge Medical Center Recruiting
Cambridge, Minnesota, United States, 55008
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Fairview Maple Grove Medical Center Recruiting
Maple Grove, Minnesota, United States, 55369
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Health Partners Inc Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Monticello Cancer Center Recruiting
Monticello, Minnesota, United States, 55362
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Fairview Northland Medical Center Recruiting
Princeton, Minnesota, United States, 55371
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Minnesota Oncology Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Fairview Lakes Medical Center Recruiting
Wyoming, Minnesota, United States, 55092
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
United States, Missouri
Saint Louis Cancer and Breast Institute-Ballwin Recruiting
Ballwin, Missouri, United States, 63011
Contact: Site Public Contact    314-251-7058      
Principal Investigator: Jay W. Carlson         
Parkland Health Center-Bonne Terre Recruiting
Bonne Terre, Missouri, United States, 63628
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Cox Cancer Center Branson Recruiting
Branson, Missouri, United States, 65616
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-334-2230    sfmc@sfmc.net   
Principal Investigator: Bryan A. Faller         
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-651-5550      
Principal Investigator: Bryan A. Faller         
Siteman Cancer Center at West County Hospital Recruiting
Creve Coeur, Missouri, United States, 63141
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Mark A. Schroeder         
Capital Region Southwest Campus Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Site Public Contact    573-632-4814    swooden@mail.crmc.org   
Principal Investigator: Bryan A. Faller         
Freeman Health System Recruiting
Joplin, Missouri, United States, 64804
Contact: Site Public Contact    417-347-4030    LJCrockett@freemanhealth.com   
Principal Investigator: Jay W. Carlson         
Mercy Hospital Joplin Recruiting
Joplin, Missouri, United States, 64804
Contact: Site Public Contact    417-556-3074    esmeralda.carrillo@mercy.net   
Principal Investigator: Jay W. Carlson         
Delbert Day Cancer Institute at PCRMC Recruiting
Rolla, Missouri, United States, 65401
Contact: Site Public Contact    573-458-7504    jrichards@research.pcrmc.com   
Principal Investigator: Jay W. Carlson         
Mercy Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Site Public Contact    573-458-7504    jrichards@research.pcrmc.com   
Principal Investigator: Jay W. Carlson         
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64507
Contact: Site Public Contact    816-271-7937    linda.schumacher@mymlc.com   
Principal Investigator: Jay W. Carlson         
Saint Louis Cancer and Breast Institute-South City Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Site Public Contact    314-353-1870      
Principal Investigator: Jay W. Carlson         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Mark A. Schroeder         
Mercy Hospital South Recruiting
Saint Louis, Missouri, United States, 63128
Contact: Site Public Contact       janet.lesko@mercy.net   
Principal Investigator: Jay W. Carlson         
Siteman Cancer Center-South County Recruiting
Saint Louis, Missouri, United States, 63129
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Mark A. Schroeder         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Site Public Contact    314-251-7066      
Principal Investigator: Jay W. Carlson         
Siteman Cancer Center at Saint Peters Hospital Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Mark A. Schroeder         
Sainte Genevieve County Memorial Hospital Recruiting
Sainte Genevieve, Missouri, United States, 63670
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
Missouri Baptist Sullivan Hospital Recruiting
Sullivan, Missouri, United States, 63080
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Missouri Baptist Outpatient Center-Sunset Hills Recruiting
Sunset Hills, Missouri, United States, 63127
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Mercy Hospital Washington Recruiting
Washington, Missouri, United States, 63090
Contact: Site Public Contact    636-390-1600      
Principal Investigator: Jay W. Carlson         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact    402-354-5144      
Principal Investigator: Stefano R. Tarantolo         
United States, North Carolina
FirstHealth of the Carolinas-Moore Regional Hospital Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Site Public Contact    910-715-3500    jcwilliams@firsthealth.org   
Principal Investigator: Charles S. Kuzma         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Carrie H. Yuen         
Mercy Hospital Oklahoma City Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Site Public Contact    405-752-3402      
Principal Investigator: Jay W. Carlson         
Oklahoma Cancer Specialists and Research Institute-Tulsa Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Site Public Contact    918-505-3200      
Principal Investigator: Carrie H. Yuen         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Public Contact    503-494-1080    trials@ohsu.edu   
Principal Investigator: Sarah J. Nagle         
United States, South Carolina
Ralph H Johnson VA Medical Center Recruiting
Charleston, South Carolina, United States, 29401
Contact: Site Public Contact    843-789-7020    ashley.salvo@va.gov   
Principal Investigator: Rinah I. Shopnick         
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Site Public Contact    864-603-6213    meissa_beckman@bshsi.org   
Principal Investigator: Robert D. Siegel         
Saint Francis Cancer Center Recruiting
Greenville, South Carolina, United States, 29607
Contact: Site Public Contact    864-603-6213    meissa_beckman@bshsi.org   
Principal Investigator: Robert D. Siegel         
United States, Wisconsin
Cancer Center of Western Wisconsin Recruiting
New Richmond, Wisconsin, United States, 54017
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Janssen, LP
Adaptive
Investigators
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Principal Investigator: Amrita Krishnan, MD, FACP City of Hope Medical Center
Principal Investigator: Parameswaran Hari, MD Medical College of Wisconsin

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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT04071457     History of Changes
Other Study ID Numbers: S1803
U10CA180888 ( U.S. NIH Grant/Contract )
NCI-2018-02465 ( Other Identifier: NCI )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Daratumumab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents