Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Carfilzomib Plus Dexamethasone in Adults With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512353
Recruitment Status : Terminated (Sponsor Decision)
First Posted : April 30, 2018
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The primary objective was to describe the safety profile of carfilzomib plus dexamethasone regimen in adults with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy at study entry.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: Dexamethasone Drug: Carfilzomib Phase 2

Detailed Description:
This is a phase 2, multicenter, open-label study in adults with RRMM in US community oncology centers. Adults with 1-3 prior lines of therapy at study entry are eligible to be screened for participation. Patients refractory to their last line of treatment are eligible to participate as long as their last line of treatment did not include a proteasome inhibitor (PI). The study will consist of a screening period of up to 28 days for bone marrow assessments and up to 21 days for all other assessments, up to 12 cycles of treatment, and a 30-day safety follow-up period following the last dose of study drug.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase 2 Study of Carfilzomib Plus Dexamethasone To Assess Tolerability and Adherence in Subjects With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers
Actual Study Start Date : July 5, 2018
Actual Primary Completion Date : January 16, 2020
Actual Study Completion Date : January 16, 2020


Arm Intervention/treatment
Experimental: Carfilzomib Plus Dexamethasone

Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12.

Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.

Drug: Dexamethasone
Dexamethasone will be taken orally or by IV infusion at a dose of 20 mg once-daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1-6, and at a dose 40 mg once-daily on days 1, 8, 15 of cycles 7-12.

Drug: Carfilzomib
Carfilzomib will be administered at 20 mg/m² on days 1 and 2 of the first cycle. After that, carfilzomib will be administered at 56 mg/m² on days 8, 9, 15, and 16 of the first cycle, and then on days 1, 2, 8, 9, 15, and 16 on each 28-day cycle for the cycles 2 through 6. Starting with cycle 7 through cycle 12, carfilzomib will be administered at 70 mg/m² on days 1, 8, and 15 of each 28-day cycle. All
Other Name: Kyprolis®




Primary Outcome Measures :
  1. Number of Participants Who Completed 12 Cycles of Treatment [ Time Frame: 12 cycles (each cycle is 28 days) ]
  2. Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 12 [ Time Frame: Up to 12 cycles (each cycle is 28 days) ]
    Percentage of expected dose of carfilzomib is defined as the percentage of actual cumulative dose (mg/m²) received by the participant relative to the full intended cumulative dose (mg/m²).

  3. Relative Dose Intensity of Carfilzomib in Cycles 1 to 12 [ Time Frame: Up to 12 Cycles (each cycle is 28 days) ]
    Relative dose intensity = actual dose intensity / planned dose intensity * 100, where dose intensity is the cumulative dose (mg) divided by the duration of the study drug administration (weeks).

  4. Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 12 [ Time Frame: Cycles 1 - 12 (each cycle is 28 days) ]
    Dose modification includes dosage adjustments, delays or discontinuations. A participant is counted only once for a reason category if there were multiple occurrences for the same reason. Participants may be counted in more than one category.

  5. Number of Participants With Treatment-emergent Adverse Events [ Time Frame: From the first dose of study drug until 30 days after the last dose (12 months) ]

    Treatment-emergent adverse events are defined as any adverse event with an onset date from the first dose through 30 days after the last dose of any study drug.

    Treatment-emergent related adverse events are adverse events considered related to at least one study drug by the investigator.

    Adverse events were graded using Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03, where Grade 1: Mild (asymptomatic or mild symptoms) Grade 2: Moderate (minimal, local or noninvasive intervention indicated) Grade 3: Severe (severe) or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated) Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.



Secondary Outcome Measures :
  1. Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 6 and 7 to 12 [ Time Frame: Cycles 1-6 and 7-12 (each cycle is 28 days) ]
    Percentage of expected dose of carfilzomib is defined as the percentage of actual cumulative dose (mg/m²) received by the participant relative to the full intended cumulative dose (mg/m²).

  2. Relative Dose Intensity of Carfilzomib in Cycles 1 to 6 and 7 to 12 [ Time Frame: Cycles 1 - 6 and 7 - 12 (each cycle is 28 days) ]
    Relative dose intensity = actual dose intensity / planned dose intensity * 100, where dose intensity is the cumulative dose (mg) divided by the duration of the study drug administration (weeks).

  3. Number of Participants With Carfilzomib Dose Modifications During Cycles 1 to 6 [ Time Frame: Cycles 1 - 6 (each cycle is 28 days) ]
    Dose modification includes dosage adjustments, delays or discontinuations. A participant is counted only once for a reason category if there were multiple occurrences for the same reason. Participants may be counted in more than one category.

  4. Number of Participants With Carfilzomib Dose Modifications During Cycles 7 to 12 [ Time Frame: Cycles 7 - 12 (each cycle is 28 days) ]
    Dose modification includes dosage adjustments, delays or discontinuations. A participant is counted only once for a reason category if there were multiple occurrences for the same reason. Participants may be counted in more than one category.

  5. Number of Participants Who Discontinued Carfilzomib in Cycles 1 to 6 and 7 to 12 [ Time Frame: Cycles 1 - 6 and 7 - 12 (each cycle is 28 days) ]
    Treatment discontinuation for all reasons in cycles 1 - 6 and cycles 7 - 12

  6. Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30) [ Time Frame: Baseline (cycle 1 day 1) to cycle 12 day 1 ]

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) is a 30-item questionnaire used to assess the overall quality of life in cancer patients. EORTC QLQ-C30 was administered on day 1 of each treatment cycle. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact).

    For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.


  7. Change From Baseline in Average EORTC QLQ-C30 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment [ Time Frame: Baseline (cycle 1 day 1) and cycles 2 - 6 ]

    EORTC QLQ-C30 was administered on day 1 of each treatment cycle. EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact).

    For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the average score from cycles 2 to 6 and the score on cycle 1 day 1.


  8. Change From Cycle 7 Day 1 in Average EORTC QLQ-C30 Scores During Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment [ Time Frame: Cycle 7 day 1 and cycles 8 - 12 ]

    EORTC QLQ-C30 was administered on day 1 of each treatment cycle. EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact).

    For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicates an improvement in symptoms.

    Change was calculated as the difference in the average score from cycles 8 to 12 and the score on cycle 7 day 1.


  9. Change From Baseline to Last Cycle of Treatment in EORTC QLQ Multiple Myeloma Module (MY-20) Scores [ Time Frame: Baseline (cycle 1 day 1) and cycle 12 day 1 ]

    EORTC QLQ-MY20 is a 20-item questionnaire used in clinical research to assess health-related quality of life in multiple myeloma patients. Questions are answered on a 4-point scale from 1 'Not at All' to 4 'Very Much'.

    The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective).

    Domain scores are calculated as averages and transformed to range from 0 to 100.

    For the Disease symptoms and side-effects of treatments scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. For the body image and future perspectives scales a higher score represents a higher level of functioning, and a positive change from baseline indicates improvement.


  10. Change From Baseline in Average EORTC QLQ-MY20 Scores During Cycles 2 to 6 in Participants Who Completed 12 Cycles of Treatment [ Time Frame: Baseline (cycle 1 day 1) and cycles 2 - 6 ]

    EORTC QLQ-MY20 is a 20-item questionnaire used in clinical research to assess health-related quality of life in multiple myeloma patients. Questions are answered on a 4-point scale from 1 'Not at All' to 4 'Very Much'.

    The QLQ-MY20 includes four domains (Disease Symptoms, Side-effects of Treatment, Body Image and Future Perspective).

    Domain scores are calculated as averages and transformed to range from 0 to 100.

    For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. For the body image and future perspectives scales a higher score represents a higher level of functioning, and a positive change from baseline indicates improvement.

    Change from baseline is the difference in the average score from cycles 2 to 6 and the score on cycle 1 day 1.


  11. Change From Cycle 7 Day 1 in Average EORTC QLQ-MY20 Scores Over Cycles 8 to 12 in Participants Who Completed 12 Cycles of Treatment [ Time Frame: Cycle 7 day 1 and cycles 8 - 12 ]

    EORTC QLQ-MY20 is a 20-item questionnaire used in clinical research to assess health-related quality of life in multiple myeloma patients. Questions are answered on a 4-point scale from 1 'Not at All' to 4 'Very Much'.

    The QLQ-MY20 includes four domains (Disease Symptoms, Side- Effects of Treatment, Body Image and Future Perspective).

    Domain scores are calculated as averages and transformed to range from 0 to 100.

    For the disease symptoms and side effects of treatments scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms. For the body image and future perspectives scales a higher score represents a higher level of functioning, and a positive change from baseline indicates improvement.

    Change was calculated as the difference in the average score from cycles 8 to 12 and the score on cycle 7 day 1.


  12. Overall Response Rate (ORR) [ Time Frame: Disease assessments were performed every 28 days up to 12 months from enrollment. ]

    Disease response and progression were determined using International Myeloma Working Group Uniform Response Criteria (IMWG-URC) 2016, assessed by the Investigator. Per IMWG, determination of disease response requires: serum free light chain (SFLC), serum and urine protein electrophoresis (SPEP, UPEP, respectively), serum and urine immunofixation (SIFE, UIFE, respectively), bone marrow aspirate (for complete response confirmation), corrected calcium (cCa), and plasmacytoma evaluation, if present at screening.

    Best overall response is defined as a participant's best response during the study. Overall response rate is defined as the percentage of participants achieving a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).


  13. Overall Response Rate (ORR) After 6 Cycles [ Time Frame: Disease assessments were performed every 28 days up to 6 cycles of treatment (each cycle was 28 days) ]

    Disease response and progression were determined using International Myeloma Working Group Uniform Response Criteria (IMWG-URC) 2016, assessed by the Investigator. Per IMWG, determination of disease response requires: serum free light chain (SFLC), serum and urine protein electrophoresis (SPEP, UPEP, respectively), serum and urine immunofixation (SIFE, UIFE, respectively), bone marrow aspirate (for CR confirmation), corrected calcium, and plasmacytoma evaluation, if present at screening.

    Overall response rate after 6 cycles is defined as the percentage of participants achieving a best overall response during the first 6 treatment cycles of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).


  14. Overall Response Rate (ORR) by Prior Lines of Therapy [ Time Frame: Disease assessments were performed every 28 days up to 12 months from enrollment. ]

    Disease response and progression were determined using International Myeloma Working Group Uniform Response Criteria (IMWG-URC) 2016, assessed by the Investigator. Per IMWG, determination of disease response requires: serum free light chain (SFLC), serum and urine protein electrophoresis (SPEP, UPEP, respectively), serum and urine immunofixation (SIFE, UIFE, respectively), bone marrow aspirate (for CR confirmation), corrected calcium, and plasmacytoma evaluation, if present at screening.

    Best overall response is defined as a participant's best response during the study. Overall response rate is defined as the percentage of participants achieving a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).


  15. Percentage of Participants With Progression-free Survival (PFS) Events at 12 Months [ Time Frame: 12 months ]

    Progression-free survival events include disease progression or death due to any cause.

    Disease progression was determined by the Investigator according to IMWG criteria.


  16. Percentage of Participants With PFS Events by Prior Lines of Therapy [ Time Frame: Disease assessments were performed every 28 days up to 12 months from enrollment. ]

    Progression-free survival (PFS) events include disease progression or death due to any cause.

    Disease progression was determined by the Investigator according to IMWG criteria.




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.


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

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study specific activities/procedures.
  • Males or females greater than or equal to 18 years of age.
  • Relapsed MM after last treatment or refractory while receiving non-proteasome inhibitor therapy.
  • Measurable disease with at least 1 of the following assessed within 21 days prior to enrollment:

    • Immunoglobulin G (IgG) MM: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL
    • IgA, IgD, IgE multiple myeloma: serum M protein level ≥ 0.5 g/dL
    • Urine M-protein ≥ 200 mg per 24 hours
    • In subjects without measurable serum or urine M-protein, serum free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
  • Subjects must have at least partial response (PR) to at least 1 line of prior therapy.
  • Subjects must have received at least 1 but not more than 3 prior lines of therapy for MM (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy).
  • Prior therapy with a proteasome inhibitor (PI) is allowed as long as the subject had at least a PR to most recent therapy with PI, was not removed due to toxicity (except for neuropathy), did not relapse within 60 days from discontinuation of PI, and will have at least a 6-month PI treatment-free interval from last dose received until enrollment. (Subjects may receive maintenance therapy with drugs that are not PI during this 6-month PI treatment-free interval).

Exclusion Criteria:

  • Waldenström macroglobulinemia.
  • Multiple myeloma of IgM subtype.
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • History of plasma cell leukemia.
  • Primary amyloidosis (patients with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met).
  • Subjects with nephrotic range proteinuria (greater than or equal to 3 g albumin for 24 hours urine OR greater than or equal to 2 g albumin/1 g of creatinine on a random urine specimen).
  • Myelodysplastic syndrome.
  • History of other malignancy within the past 5 years, with the following exceptions:

    • Malignancy treated with curative intent and with no known active disease present for greater than or equal to 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated cervical carcinoma in situ without evidence of disease.
    • Adequately treated breast ductal carcinoma in situ without evidence of disease.
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer.
    • Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
    • Treated medullary or papillary thyroid cancer.
    • Similar neoplastic conditions with an expectation of greater than 95% five-year disease-free survival.
  • Known human immunodeficiency virus (HIV) infection, hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response following antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response with antiviral therapy directed at hepatitis B are allowed).
  • Acute or chronic graft-versus-host disease (any grade).
  • Acute active infection requiring systemic antibiotics, antifungal, antiviral (except antiviral therapy directed at hepatitis B) agents within 14 days prior to enrollment.
  • Known cirrhosis.
  • Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to enrollment.
  • Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment.
  • Uncontrolled hypertension, defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg. Subjects with controlled hypertension are eligible.
  • Hepatic dysfunction within 21 days prior to enrollment: bilirubin 1.5 times the upper limit of normal (ULN) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 3 times the ULN
  • Active congestive heart failure with or without reduced ejection fraction (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT interval (QTc) of greater than 470 msec, pericardial disease, myocardial infarction within 4 months prior to enrollment.
  • Known chronic obstructive pulmonary disease.
  • Known interstitial pneumonitis.
  • Immunotherapy within 21 days prior to enrollment.
  • Chemotherapy with approved anticancer therapeutic within 21 days prior to enrollment.
  • Glucocorticoid therapy (prednisone greater than 30 mg/day or equivalent) within 14 days prior to enrollment.
  • Focal radiation therapy within 7 days prior to enrollment. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (ie, prior radiation must have been to less than 30% of the bone marrow).
  • Major surgery (except kyphoplasty) within 28 days prior to enrollment.
  • Autologous or allogeneic stem cell transplant within 90 days prior to enrollment.
  • Contraindication to dexamethasone.
  • Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib).
  • Intolerance to intravenous (IV) hydration.
  • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
  • Hepatic dysfunction within 21 days prior to enrollment: bilirubin greater than or equal to 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 3 times the ULN.
  • Left ventricular ejection fraction less than 40% assessed by transthoracic echocardiogram.
  • Severe valvular disease assessed by transthoracic echocardiogram.
  • Severe right-ventricular dysfunction assessed by transthoracic echocardiogram.
  • Right-ventricular systolic pressure greater than 40 mm Hg assessed by transthoracic echocardiogram.
  • Screening absolute neutrophil count (ANC) should be independent of growth factor support for greater than or equal to 1 week.
  • Hemoglobin less than 80 g/L within 21 days prior to enrollment. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.
  • Platelet count < 50 x 10^9/L (≤ 30 x 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to enrollment. Subjects should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
  • Estimated glomerular filtration rate (GFR) less than 30 mL/min/1.73 m^2 (per the Chronic Kidney Disease Epidemiology Collaboration formula) within 21 days prior to enrollment.

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): NCT03512353


Locations
Layout table for location information
United States, California
Research Site
Palm Springs, California, United States, 92262
Research Site
Riverside, California, United States, 92501
United States, Colorado
Research Site
Glenwood Springs, Colorado, United States, 81601
United States, Florida
Research Site
Boynton Beach, Florida, United States, 33426
Research Site
Orange City, Florida, United States, 32763
Research Site
Pensacola, Florida, United States, 32504
United States, Hawaii
Research Site
Honolulu, Hawaii, United States, 96813
United States, Illinois
Research Site
River Forest, Illinois, United States, 60305
Research Site
Tinley Park, Illinois, United States, 60487
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Research Site
Paducah, Kentucky, United States, 42003
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20817
United States, Michigan
Research Site
Midland, Michigan, United States, 48640
United States, Mississippi
Research Site
Jackson, Mississippi, United States, 39202
United States, Nebraska
Research Site
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Research Site
Florham Park, New Jersey, United States, 07932
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28204
Research Site
Charlotte, North Carolina, United States, 28207
Research Site
Hendersonville, North Carolina, United States, 28792
Research Site
Pinehurst, North Carolina, United States, 28374
Research Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Research Site
Zanesville, Ohio, United States, 43701
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29414
Research Site
Rock Hill, South Carolina, United States, 29732
United States, Texas
Research Site
Corpus Christi, Texas, United States, 78412
Research Site
Fort Worth, Texas, United States, 76104
Research Site
Houston, Texas, United States, 77057
Research Site
Houston, Texas, United States, 77090
United States, Utah
Research Site
Ogden, Utah, United States, 84405
United States, Virginia
Research Site
Fredericksburg, Virginia, United States, 22408
United States, Washington
Research Site
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] May 20, 2019
Statistical Analysis Plan  [PDF] June 8, 2018

Additional Information:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03512353    
Other Study ID Numbers: 20170596
First Posted: April 30, 2018    Key Record Dates
Results First Posted: January 8, 2021
Last Update Posted: January 8, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing

Layout table for additional information
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
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents