Health TrialsbyHealthPanel

Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for RRMM

ConditionsMultiple Myeloma in RelapseMultiple Myeloma, Refractory
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorDong-A University Hospital

About this trial

This study aims to study the efficacy and safety of oral cyclophosphamide in addition to carfilzomib and dexamethadone for RRMM patients who have been previously exposed to lenalidomide combination therapies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects aged 19 years or older

ECOG performance status 0 to 2

Diagnosed with multiple myeloma by IMWG criteria

Subjects previously treated with 1 or more lines of therapy

Disqualifiers

Myocardial infarction within 6 months prior to treatment, New York Heart Association class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease,

Uncontrolled arrythmias (CVDAE version4 grade 2 or more) or symptomatic EKG abnormalities

12-lead EKG : baseline ATcF > 470msec

2D Echocardiography or MUGA scan : systolic EF < 40% with clinically significant symptoms

Trial design

Design model

Single group

Treatments tested in this trial

  • Carfilzomib

    Drug

    70 mg/m2 IV days 1, 8 and 15, every 4 weeks

  • Cyclophosphamide

    Drug

    50 mg PO days 1 to 21, every 4 weeks

  • Dexamethasone

    Drug

    40mg PO or IV days 1, 8, 15, and 22, every 4 weeks

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: Weekly carfilzomib-oral cyclophosphamide-dexamethasoneExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Very good partial response

Reduction of serum M-protein \> 90%

Time frame
from the first date of KCd to the day 30 after KCd stop date

Secondary outcomes

1

Overall response

sCR+CR+VGPR+PR

Time frame
from the first date of KCd to the day 30 after KCd stop date
2

Progression-free survival

the time from the first date of KCd to the date of disease progression or death or censored date

Time frame
from the first date of KCd until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
3

Overall survival

the time from the first date of KCd to the date of death or censored date

Time frame
from the first date of KCd until the date of death from any cause, assessed up to 48 months
4

Duration of response

the time from the first date of PR to the date of disease progression or death or censord date

Time frame
from the first date of PR to the date of disease progression or death or censord date, which ever came first, assessed up to 48 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dong-A University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: