Phase
Condition
Bone Neoplasm
Platelet Disorders
Leukemia
Treatment
Daratumumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with relapsed and refractory multiple myeloma (as per InternationalMyeloma Working Group [IMWG] definitions) whose prior therapy included a proteasomeinhibitor and an immunomodulatory agent, being newly initiated on DARZALEX (daratumumab) monotherapy based on independent clinical judgment of treatingphysicians as per locally approved prescribing information
Each participant (or their legally acceptable representative) must sign an informedconsent form (ICF) indicating that he or she understands the purpose of andprocedures required for the study and are willing to participate in the study.Participants must be willing and able to adhere to the prohibitions and restrictionsspecified in this protocol, as referenced in the informed consent form (ICF)
Exclusion
Exclusion Criteria:
Participants who are not eligible to receive DARZALEX as per the locally approvedprescribing information
Participant participating or planning to participate in any interventional drugtrial during the course of this study
Known seropositive for human immunodeficiency virus (HIV)
Seropositive for hepatitis B (defined by a positive test for hepatitis B surfaceantigen [HBsAg]). Participants with resolved infection (that is, participants whoare HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must bescreened using real-time polymerase chain reaction (PCR) measurement of hepatitis Bvirus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will beexcluded. exception: Participants with serologic findings suggestive of HBVvaccination (anti-HBs positivity as the only serologic marker) and a known historyof prior HBV vaccination, do not need to be tested for HBV DNA by PCR
Known seropositive for hepatitis C (except in the setting of a sustained virologicresponse [SVR], defined as aviremia at least 12 weeks after completion of antiviraltherapy)
Study Design
Connect with a study center
Avron Hospitals Pvt. Ltd
Ahmedabad, 380013
IndiaSite Not Available
M S Ramaiah Medical College and Hospital
Bengaluru, 560054
IndiaSite Not Available
Sparsh Hospitals & Critical Care (Pvt) Ltd
Bhubaneshwar, 751007
IndiaSite Not Available
Apollo Hospitals
Bhubaneswar, 751005
IndiaSite Not Available
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh, 160012
IndiaSite Not Available
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012
IndiaSite Not Available
Apollo Hospitals
Hyderabad, 500033
IndiaSite Not Available
Basavatarakam Indo-American Hospital
Hyderabad, 500034
IndiaSite Not Available
Cytecare Hospitals Pvt. Ltd
Karnataka, 560064
IndiaSite Not Available
Tata Medical Center
Kolkata, 700156
IndiaSite Not Available
Christian Medical College
Ludhiana, 141008
IndiaSite Not Available
Tata Memorial Hospital
Mumbai, 400012
IndiaSite Not Available
Shatabdi Super Speciality Hospital
Mumbai Naka, 422005
IndiaSite Not Available
Kingsway Hospital
Nagpur, 440001
IndiaSite Not Available
Apex Wellness Hospital
Nashik, 422009
IndiaSite Not Available
All India Institute of Medical Sciences
New Delhi, 110029
IndiaSite Not Available
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry, 605008
IndiaSite Not Available
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004
IndiaSite Not Available
Noble Hospital Pvt Ltd
Pune, 411013
IndiaSite Not Available
Regional Cancer Centre
Thiruvananthapuram, 695011
IndiaSite Not Available
Christian Medical College
Vellore, 632004
IndiaSite Not Available

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