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RecruitingNCT06682156Updated Nov 12, 2024

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

An observational study in Newly Diagnosed Multiple Myeloma, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by The First Affiliated Hospital of Soochow University · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is an open-label, single-arm, prospective study conducted in real-world clinical practice. Chinese patients with newly diagnosed multiple myeloma will be enrolled if they switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.

Induction and consolidation therapy will be 6-8cycles. 6 cycles for transplant recipients and 8 cycles for non-transplant recipients. Maintenance therapy will continue until progression.

It aims to evaluate the efficacy and safety of carfilzomib based therapy in Chinese NDMM patients with intolerance to bortezomib. The primary endpoint is the rate of 2-year pFS and secondary endpoints are the rate of ORR,sCR/CR,VGPR,PR, the rate and duration of MRD, the rate of 2-year OS and safety.

02

Conditions studied

  • Newly Diagnosed Multiple Myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 50 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

  1. ≥ 18 years of age
  2. Diagnosed with multiple myeloma according to IMWG criteria.
  3. 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).
  4. Eastern cooperative oncology group(ECOG) score 0-2
  5. 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.
  6. Patients who agree to and sign informed consents to participate in this study.

Exclusion criteria

Exclusion Criteria:

  1. Patients currently participating in other interventional clinical studies (except those currently participating in non-interventional observational studies)
  2. Patients who have received prior carfilzomib treatment or participated in carfilzomib associated studies (with or without carfilzomib treatment).
  3. 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)
  4. Patients who have not fully recovered from the reversible effects of prior chemotherapy (i.e., \<= grade 1 toxicity).
  5. 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.
  6. Patients with an active systemic infection, active hepatitis B or C virus infection, or known positive test results for human immunodeficiency virus.
  7. 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.
  8. 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.
  9. Inability to comply with protocol/procedure.
  10. Patients with hypersensitivity to the active ingredient or excipients of carfilzomib.
  11. Pregnant or lactating women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugCarfilzomib

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

    Also known as: Kyprolis

06

What researchers measure

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

  5. MRD negativity rate

    the rate of minimal residual disease

    Time frame: from enrollment to 2 years

  6. AE rate

    the rate of adverse events

    Time frame: from enrollment to 2 years

  7. 2-year OS rate

    the rate of Overall survival at 2 years

    Time frame: from enrollment to 2 years

  8. Duration of MRD negativity

    Duration of minimal residual disease negativity

    Time frame: from enrollment to 2 years

  9. 2-year PFS rate

    the rate of progression free survival at 2 years

    Time frame: from enrollment to 2 years

07

Study locations

1 of 1 sites recruiting
  • Lingzhi Yan
    Suzhou, Jiangsu 215006, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06682156
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Sep 10, 2024
Primary completion
Mar 31, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 12, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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