Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

Sponsor
Amgen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03937154
Collaborator
(none)
162
104
2
61
1.6
0

Study Details

Study Description

Brief Summary

To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer. Subjects must have a platelet count ≤ 85 x 10^9/L on day 1 of the study. The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and long-term follow-up (LTFU). Given that subjects are required to have 3 remaining planned cycles of chemotherapy, the chemotherapy cycles may be 3 or 4 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of 10-24 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and LTFU. Given that subjects are required to have 3 remaining planned cycles of chemotherapy, the chemotherapy cycles may be 3 or 4 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of 10-24 weeks.The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and LTFU. Given that subjects are required to have 3 remaining planned cycles of chemotherapy, the chemotherapy cycles may be 3 or 4 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of 10-24 weeks.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
Actual Study Start Date :
Feb 26, 2020
Anticipated Primary Completion Date :
Apr 28, 2024
Anticipated Study Completion Date :
Mar 29, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Romiplostim

The study in a 2:1 randomization ratio(108 subjects to romiplostim). Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

Drug: Romiplostim
This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer
Other Names:
  • Nplate
  • Placebo Comparator: Placebo

    The study in a 2:1 randomization ratio (54 subjects to placebo) Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

    Drug: Placebo
    Placebo comparator

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of either a chemotherapy dose delay or reduction [48 days]

      No thrombocytopenia-induced modification of any myelosuppressive agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L

    Secondary Outcome Measures

    1. Depth of Platelet Count [48 days]

      the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period

    2. Time to First platelet response [7 days]

      The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days

    3. the duration-adjusted event rate of ≥ grade 2 bleeding events [48 days]

      the duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale

    4. Overall survival [1 Year]

      1-year overall survival

    5. Proportion of subjects with at leat 1 incidence of platelet transfusion [48 days]

      platelet transfusion(s) during the treatment period

    6. proportion of patients achieving platelet count >= 100 x 10 9/L [7 days]

      7 days after 3rd dose of IP with no transfusions in preceding 7 days

    7. The subject incidence of adverse events [36 months]

      Through end of study, up to 36 months. It will be counted in as an adverse event: any treatment - emergent adverse events, fatal adverse events, serious adverse events, or clinically significant changes in laboratory values.

    8. Number of subjects who develop anti-romiplostim antibodies [36 Months]

      Through end of study up to 36 months

    9. Number of subjects who develop anti-TPO antibodies [36 months]

      Through end of study, up to 36 months

    10. Number of subjects who experience myelodysplastic syndromes [36 months]

      Through end of study, up to 36 months

    11. Number of subjects who experience secondary malignancies [36 months]

      Through end of study, up to 36 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subject has provided informed consent prior to initiation of any study-specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.

    • Males or females greater than or equal to 18 years of age at signing of the informed consent.

    • Documented active stage I, II, III or IV locally advanced or metastatic of the following tumor types: NSCLC, breast cancer, or ovarian cancer (includes fallopian tube epithelial carcinomas and peritoneal epithelial carcinoma of unknown primary), or any stage recurrent disease. Patients with documented locally advanced (stage III) NSCLC should not be amenable to definitive treatment with chemoradiation and/or surgery.

    • Subjects must be receiving cancer treatment with 21- or 28-day cycles, using one of the following carboplatinum-based combination chemotherapy regimens: carboplatin/gemcitabine based, carboplatin/pemetrexed based, carboplatin/liposomal doxorubicin based or carboplatin/taxane based (which includes either paclitaxel, nab-paclitaxel, or docetaxel). Use of combination regimens with one of the above carboplatinum-based regimens is permitted with (1) anti-angiogenic agents (such as bevacizumab); (2) targeted therapy (such as anti-epidermal growth factor agents or anti- human epidermal growth factor receptor 2) or (3) immune checkpoint inhibitors. Cycle duration is based on intervals between day 1 of chemotherapy cycles (overlapping with carboplatin intervals) every 21 or 28 days. OR, Subjects must have CIT from a non-protocol chemotherapy regimen, planning to start treatment with one of the above protocol chemotherapy regimens which has been delayed ≥ 1 week due to CIT.

    • Subjects must have a local platelet count ≤ 85 x 109/L on day 1 of the study.

    • Subjects must be at least 21 or 28 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if receiving a 21-day or 28-day cycle chemotherapy regimen, respectively.

    • Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

    Exclusion Criteria:
    • Acute lymphoblastic leukemia.

    • Acute myeloid leukemia.

    • Any myeloid malignancy.

    • Myelodysplastic syndrome. Baseline bone marrow biopsy is not required to rule out MDS. However, if a bone marrow biopsy and cytogenetics were performed as part of diagnostic or staging work-up, these results will be collected to confirm.

    • Myeloproliferative disease.

    • Multiple myeloma.

    • Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of greater than 470 msec, pericardial disease, or myocardial infarction.

    • Major surgery less than or equal to 28 days or minor surgery less than or equal to 3 days prior to enrollment.

    • New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. To be eligible, subjects must have received at least 14 days of anticoagulation for a new thrombotic event and considered to be stable and suitable for continued therapeutic anticoagulation during trial participation.

    • History of arterial thrombotic events (eg, myocardial ischemia, transient ischemic attack, or stroke) within 6 months prior to screening.

    • Evidence of active infection within 2 weeks prior to the first dose of study treatment.

    • Known human immunodeficiency virus infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available use central laboratory results.

    • Known active of chronic hepatitis C or hepatitis B infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available use central laboratory results. Hepatitis B and C infection is based on the following results:

    • Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).

    • Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.

    • Positive hepatitis C virus antibody: hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.

    • In addition to the conditions listed in exclusion criteria 201 through 206, secondary malignancy within the past 5 years except:

    • 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.

    • 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 (excluding malignancies listed in exclusion criteria 201 - 206).

    • Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura).

    • Any combined modality regimen containing radiation therapy or surgery occurring concomitantly with neo-adjuvant chemotherapy or where radiation therapy is planned before the 3 planned on-study cycles of chemotherapy.

    Prior/Concomitant Therapy:
    • Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent.

    Prior/Concurrent Clinical Study Experience - Currently receiving (or plan to receive) treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

    Diagnostic Assessments

    • Anemia (hemoglobin < 80 g/L [8 g/dL]) on the day of initiation of investigational product as assessed by local labs. Use of red cell transfusions and erythropoietic stimulating agents is permitted throughout the study as per institutional guidelines.

    • Neutropenia (absolute neutrophil count less than 1 x 10 9/L) on the day of initiation of investigational product as assessed by local labs. Use of granulocyte-colony stimulating factor is permitted throughout the study as per institutional guidelines.

    • Abnormal renal function with creatinine clearance less than 30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by local laboratory. If local laboratory results are not available use central laboratory results.

    during screening.

    • Abnormal liver function (total bilirubin greater than 3X ULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] greater than 3X ULN for subjects without liver metastases or greater than or equal to 5X ULN for subjects with liver metastases) as assessed by local laboratory during screening. If local laboratory results are not available use central laboratory results.

    Other Exclusions

    • Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 months after treatment (and chemotherapy) discontinuation (females of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.)

    • Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and for an additional 7 months after treatment (and chemotherapy) discontinuation. Refer to Appendix 5 for additional contraceptive information.

    • Males unwilling to use contraception* (male condom or sexual abstinence) or their female partner(s) of childbearing potential who are unwilling to use a highly effective method of contraception during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation. *If the male's sole partner is of non-childbearing potential, he is not required to use additional forms of contraception during the study.

    • Subject has known sensitivity to any of the products to be administered during dosing.

    • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, COAs) to the best of the subject and investigator's knowledge.

    • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

    • Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation.

    • Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Bernards Medical Center Jonesboro Arkansas United States 72401
    2 Pacific Cancer Medical Center Inc Anaheim California United States 92801
    3 University of California at Irvine Medical Center Orange California United States 92868
    4 Colorado West Healthcare System dba Grand Valley Oncology Grand Junction Colorado United States 81505
    5 Ocala Oncology Center Ocala Florida United States 34474
    6 Mid Florida Hematology and Oncology Centers PA Orange City Florida United States 32763
    7 Saint Alphonsus Regional Medical Center Boise Idaho United States 83706
    8 Orchard Healthcare Research Inc Skokie Illinois United States 60076
    9 Christus Saint Frances Cabrini Hospital Alexandria Louisiana United States 71301
    10 University Medical Center New Orleans New Orleans Louisiana United States 70112
    11 CHRISTUS Highland Cancer Treatment Center Shreveport Louisiana United States 71105
    12 Mercy Medical Center Baltimore Maryland United States 21202
    13 American Oncology Partners of Maryland, PA Bethesda Maryland United States 20817
    14 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    15 Hattiesburg Clinic Hematology/Oncology Hattiesburg Mississippi United States 39401
    16 Oncology Hematology Associates Springfield Missouri United States 65807
    17 Regional Cancer Care Associates Sparta New Jersey United States 07871
    18 Broome Oncology LLC Binghamton New York United States 13905
    19 Saint Lukes University Health Network Bethlehem Pennsylvania United States 18015
    20 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
    21 Medical Oncology Associates PS Spokane Washington United States 99208
    22 Yakima Valley Memorial Hospital Yakima Washington United States 98902
    23 Instituto Oncologico Cordoba Ciudad de Cordoba Córdoba Argentina X5002HWE
    24 Centro Medico Austral Ciudad Autónoma de Buenos Aires Distrito Federal Argentina C1019ABS
    25 Centro de Investigaciones Clínicas Clínica Viedma Viedma Río Negro Argentina 8500
    26 Medizinische Universitaet Innsbruck Innsbruck Austria 6020
    27 Instituto de Oncologia do Parana Curitba Paraná Brazil 81520-060
    28 Vencer e Oncoclinica Teresina Piauí Brazil 64049-200
    29 Centro de Pesquisa da Serra Gaucha - Cepesg Caxias do Sul Rio Grande Do Sul Brazil 95020-450
    30 Catarina Pesquisa Clinica Itajaí Santa Catarina Brazil 88301-220
    31 Loema Instituto de Pesquisa Clinica & Consultores Ltda Campinas São Paulo Brazil 13010-001
    32 Casa de Saude Santa Marcelina Sao Paulo São Paulo Brazil 08270-120
    33 Complex Oncology Center - Ruse EOOD Ruse Bulgaria 7002
    34 Multiprofile Hospital for Active Treatment Serdika EOOD Sofia Bulgaria 1632
    35 Specialized Hospital for Active Treatment of Oncology EAD Sofia Bulgaria 1756
    36 James Lind Centro de Investigacion del Cancer Temuco Cautín Chile 4800827
    37 Orlandi Oncologia Santiago Chile 7500713
    38 Oncomedica Imat Monteria Córdoba Colombia 230002
    39 Centro Medico Imbanaco Cali Valle Del Cauca Colombia 760042
    40 Agios Savvas Anticancer Hospital Athens Greece 115 22
    41 Henry Dunant Hospital Center Athens Greece 11526
    42 Sotiria General Hospital Athens Greece 11527
    43 Attikon University Hospital Athens Greece 12462
    44 University Hospital of Heraklion Heraklion - Crete Greece 71110
    45 Agios Loukas Clinic Thessaloniki Greece 55236
    46 Iatriko Diavalkaniko Thessalonikis Thessaloniki Greece 57001
    47 Semmelweis Egyetem Budapest Hungary 1083
    48 Veszprem Megyei Tudogyogyintezet Farkasgyepu Hungary 8582
    49 Petz Aladar Egyetemi Oktato Korhaz Gyor Hungary 9024
    50 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar Hungary 8000
    51 Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet Szolnok Hungary 5004
    52 Tudogyogyintezet Torokbalint Torokbalint Hungary 2045
    53 Oncotech La Paz Baja California Sur Mexico 23040
    54 Centro de Atencion e Investigacion Cardiovascular del Potosi Sc San Luis Potosi San Luis Potosí Mexico 78200
    55 Centro Medico Nacional Siglo XXI Mexico Mexico 06720
    56 Oaxaca Site Management Organization SC Oaxaca Mexico 68000
    57 Hospital Goyeneche Arequipa Peru 04001
    58 Oncosalud Lima Peru 15036
    59 Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o Brzeziny Poland 95-060
    60 Szpital Kliniczny im Heliodora Swiecickiego UM im Karola Marcinkowskiego w Poznaniu Poznan Poland 60-569
    61 Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente Lisboa Portugal 1769-001
    62 Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano Matosinhos Portugal 4464-513
    63 Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio Porto Portugal 4099-001
    64 Hospital de Sao Joao, EPE Porto Portugal 4200-319
    65 Institutul Oncologic, Prof Dr Alexandru Trestioreanu Bucharest Romania 022328
    66 Institutul Oncologic, Prof Dr Alexandru Trestioreanu Bucharest Romania 022338
    67 Spitalul Clinic Coltea Bucharest Romania 030171
    68 Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca Cluj Napoca Romania 400015
    69 Institutul Regional de Oncologie Iasi Iasi Romania 700483
    70 Spitalul Municipal Ploiesti Ploiesti Romania 100337
    71 SC Oncomed SRL Timisoara Romania 300239
    72 SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary Arkhangelsk Russian Federation 163045
    73 Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan Kazan Russian Federation 420029
    74 Medsi Group Moscow Region Russian Federation 143442
    75 State Healthcare Institution Goroda Moskvi City Clinical Hospital 1 Moscow Russian Federation 119049
    76 Clinical hospital 2, Group of companies medsi Moscow Russian Federation 125284
    77 LLC Tonus Nizhniy Novgorod Russian Federation 603089
    78 Omsk Regional Clinical Oncology Dispensary Omsk Russian Federation 644013
    79 State budget institution of public health Pyatigorsk oncology dispensary Pyatigorsk Russian Federation 357502
    80 State Institution of Public Health Ryazan Russian Federation 390011
    81 State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region Sochi Russian Federation 354057
    82 State Institution of Public Health Tambov Regional Oncology Dispensary Tambov Russian Federation 390013
    83 Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan Ufa Russian Federation 450054
    84 Hospital Clinico Universitario San Cecilio Granada Andalucía Spain 18016
    85 Hospital Universitario Nuestra Señora de Valme Sevilla Andalucía Spain 41013
    86 Hospital Clinico Universitario de Salamanca Salamanca Castilla León Spain 37007
    87 Instituto Oncologico IOB Barcelona Cataluña Spain 08023
    88 Consorcio Hospitalario Provincial de Castellon Castellon Comunidad Valenciana Spain 12002
    89 Hospital Santa Maria Nai Ourense Galicia Spain 32005
    90 Hospital Universitario Madrid Sanchinarro Madrid Spain 28050
    91 Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi Ankara Turkey 06200
    92 Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho Ankara Turkey 06280
    93 Pamukkale Universitesi Tip Fakultesi Hastanesi Denizli Turkey 20070
    94 Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Edirne Turkey 22030
    95 Istanbul Universitesi Cerrahpasa Tip Fakultesi Istanbul Turkey 34098
    96 Pendik Egitim Arastirma Hastanesi Istanbul Turkey 34890
    97 Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi Izmir Turkey 35150
    98 Medical Park Izmir Hastanesi Izmir Turkey 35575
    99 Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Kocaeli Turkey 41380
    100 Inonu Universitesi Turgut Ozal Tip Merkezi Malatya Turkey 44280
    101 Namik Kemal Universitesi Hastanesi Tekirdag Turkey 59100
    102 Communal Institution Chernivtsi Regional Clinical Oncological Dispensary Chernivtsi Ukraine 58013
    103 Transcarpathian Regional Clinical Oncological Dispensary Uzhgorod Ukraine 88011
    104 Vinnytsya Regional Clinical Oncological Dispensary Vinnytsia Ukraine 21029

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT03937154
    Other Study ID Numbers:
    • 20170770
    First Posted:
    May 3, 2019
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2022