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NCT06682156Recruiting

Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients

Clinical Outcome of Multiple Myeloma Patients Switching to Carfilzomib-based Regimens After Prior Bortezomib-based First-line Therapy Intolerant, a Real-world, Single-arm, Prospective Study

Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
7 Nov 2024
Start date
10 Sept 2024
Primary completion date
31 Mar 2028
Lead sponsor
The First Affiliated Hospital of Soochow University
NCT number
NCT06682156

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 10 Sept 2024 to the primary completion date, 31 Mar 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have received prior carfilzomib treatment or participated in carfilzomib associated studies (with or without carfilzomib treatment).
  • Patients who have not fully recovered from the reversible effects of prior chemotherapy (i.e., \<= grade 1 toxicity).
  • Patients with other malignancies diagnosed prior to the MM diagnosis, excluding squamous and basal cell carcinomas of the skin, and carcinoma in situ of the cervix or breast, which can be cured within 3 years with minimal risk of recurrence.

Other illness

  • Patients with an active systemic infection, active hepatitis B or C virus infection, or known positive test results for human immunodeficiency virus.
  • Participants with known chronic obstructive pulmonary disease (COPD) (defined as forced expiratory volume in 1 second \[FEV1\] \<50% of predicted normal value), persistent asthma, or a history of asthma within the past 2 years (controlled intermittent asthma or mild persistent asthma that is allowed). Participants with known or suspected COPD must undergo FEV1 testing during screening.
  • Patients with hypersensitivity to the active ingredient or excipients of carfilzomib.

Lab values

  • Patients with a primary diagnosis of MM combined with plasma cell leukemia (peripheral blood monoclonal plasma cells ≥5% of the total number of differentiated mature leukocytes)
  • Evidence of current uncontrolled cardiovascular disease, including hypertension, arrhythmias (prolonged QT interval, ventricular tachycardia, ventricular flutter, ventricular fibrillation, frequent ventricular premature beats (24-hour premature loading of ≥15% of the total number of beats), grade Ⅲ atrioventricular block, and a heart rate of \<30-40 bpm congestive heart failure, unstable angina, or myocardial infarction in the past 3 months,. New York Heart Association (NYHA) class III and IV heart failure. left ventricle ejection fraction(LVEF) \<40% on cardiac ultrasound.

Other

  • Patients currently participating in other interventional clinical studies (except those currently participating in non-interventional observational studies)
  • Inability to comply with protocol/procedure.
  • Pregnant or lactating women

Who the study is looking for

  • ≥ 18 years of age
  • Diagnosed with multiple myeloma according to IMWG criteria.
  • Patients who have received only first-line bortezomib-based triple therapy, including bortezomib/lenalidomide/dexamethasone (VRD), bortezomib/thalidomide/dexamethasone (VTD),bortezomib/ cyclophosphamide/dexamethasone (VCD), and bortezomib/adriamycin//dexamethasone (PAD).
  • Eastern cooperative oncology group(ECOG) score 0-2
  • Patients who develop toxicities associated with bortezomib therapy evaluated by the investigator, including the presence of Grade 1 with pain or Grade 2 peripheral neuropathy (PN), Grade 3 hepatic impairment, Grade 3 diarrhea, and any other Grade 3 non-hematologic adverse events and resulting in bortezomib dose reduction or discontinuation.
  • Patients who agree to and sign informed consents to participate in this study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Lingzhi Yan
Coordinator of this site? Confirm its status
SuzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.