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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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

Disqualifiers

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).

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Carfilzomib

    Drug

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: K-based therapy1 intervention

Trial outcomes

Primary outcomes

1

Outcome of peripheral neuropathy

recurrence of peripheral neuropathy

Time frame
from enrollment to 2 years

Secondary outcomes

1

ORR

the rate of sCR,CR, PR and VGPR according to IMWG(International Myeloma Working Group) criteria

Time frame
from enrollment to 2 years
2

sCR/CR rate

the rate of sCR/CR according to IMWG criteria

Time frame
from enrollment to 2 years
3

PR rate

the rate of PR according to IMWG criteria

Time frame
from enrollment to 2 years
4

VGPR rate

the rate of VGPR according to IMWG criteria

Time frame
from enrollment to 2 years

Other outcomes

Sponsors and contacts

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