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

NCT06682156 | Recruiting

• 1 other identifier: Kcv-MM12
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newly Diagnosed Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Outcome of peripheral neuropathy

  recurrence of peripheral neuropathy

  from enrollment to 2 years

Secondary Outcomes (9)

• ORR

  from enrollment to 2 years

• sCR/CR rate

  from enrollment to 2 years

• PR rate

  from enrollment to 2 years

• VGPR rate

  from enrollment to 2 years

• MRD negativity rate

  from enrollment to 2 years

Study Arms (1)

K-based therapy

if bortezomib related intolerance happens during front line therapy of bortezomib-based triple regimen, then carfilzomib-based therapy will be used

Drug: Carfilzomib

Interventions

Carfilzomib DRUG

carfilzomib C1: 20mg/m2，D1-2; 27mg/m2，D8-9; 36mg/m2，D15-16 C2 and subsequent cycles: 36mg/m2。

Also known as: Kyprolis

K-based therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed multiple myeloma 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

You may qualify if:

• ≥ 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.

You may not qualify if:

• Patients currently participating in other interventional clinical studies (except those currently participating in non-interventional observational studies)
• Patients who have received prior carfilzomib treatment or participated in carfilzomib associated studies (with or without carfilzomib treatment).
• 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)
• 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.
• Patients with an active systemic infection, active hepatitis B or C virus infection, or known positive test results for human immunodeficiency virus.
• 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.
• 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.
• Inability to comply with protocol/procedure.
• Patients with hypersensitivity to the active ingredient or excipients of carfilzomib.
• Pregnant or lactating women

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

Lingzhi Yan

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Interventions

carfilzomib

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 12, 2024

Record last verified: 2024-04

Locations

CN (1)