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Multiple Myeloma in RelapsePhase 2KMM-KCdNCT05909826

Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for RRMM

A Phase 2 study testing Carfilzomib, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Dong-A University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Carfilzomib, Cyclophosphamide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
No sites listed yet
Study dates
1 Jul 2023to 30 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Subjects previously treated with lenalidomide-based combination or sigle drug therapy
  • Subjects with relapsed and/or refractory multiple myeloma
Show all 23Show fewer
  • Subjects with measurable disease at the time of treatment initiation
  • serum M protein >=0.5 g/dL, or
  • 24h urine M protein >= 200mg/24h
  • serum free light chain difference >=10mg/dL and abnormal FLC ratio
  • Adequate organ function
  • absolute neutrophil count >= 1.0 x 109/L
  • platelelt count >= 50 x 109/L (plasmacytoma in the bone: >=30 x 109/L)
  • Hb >=8g/dL
  • serum creatinine < 3.0mg/dL or CCR >=15mL/min
  • serum AST and ALT <=3 x ULN
  • serum total bilirubin <= 3 x ULN
  • Subjects able to swallow oral drugs
  • Subjects who had experienced toxicities to previous therapies: resolved from previous toxicities or stabilized of the toxicity to grade 1
  • Subjects who had received allogenetic stem cell transplantation: no acitve graft-versus-host disease
  • Subjects without clinically relevant bleeding
  • Subjects who have informed consent to the study
  • Females of childbearing potential (FCBP) must be negative to pregnancy testing and give consent to practice contraception before and during the treatment

Who cannot join

  • 1. Subjects who were previously exposed to carfilzomib
  • 1. Subjects who were previously exposed to cyclophosphamide 3. Subjects diagnosed with POEMS SD, Waldenstrom macroglobulinemia, Plasma cell leukemia 4. Subjects with concurrent heart conditions
  • 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
  • Uncontrolled hypertension ( with medication: systolic BP >= 160 mmHg or diastolic BP >= 100 mmHg) 5. Chronc obstructive pulmonary disease (FEV1 < 60%), history of asthma within 2 years 6. Surgery under general anesthesia withing 2 weeks 7. Subjects diagnosed with malignancies within 5 years (except for cured skin cancer, cervical cancer, intraepithelial gastrointestinal tract cancer after curative procedures or surgery for more than 3 years) 8. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent 9. Pregnant or breatfeeding subjecs

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ji Hyun Lee, MD, Ph.D contact

82-51-240-2915

hidrleejh@dau.ac.kr

About this study

Official title: A Phase II Study of Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma

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.

Read the detailed description

The survival of multiple myeloma (MM) patients has been improved significantly owing to the adoption of immunomodulatory agents (IMiD) and proteasome inhibitors (PI). However, most of the MM patients finally experience relapse of refractoriness of the disease, of which patients who relapse after bortezomib and lenalidomide have very poor prognosis. Carfilzomib is an irreversible second generation PI which is approved by Korean FDA for RRMM in combination with dexamethasone and/or lenalidomide based on the landmark studies ASPIRE and ENDEAVOR studies. The addition of intravenous cyclophosphamide to carfilzomib has recently showed a promising result for RRMM patients after bortezomib and lenalidomide. In this study, cyclophosphamide 50mg orally will be added to carfilzomib once weekly schedule for 21 days daily every 4 weeks. The rationale for oral metronomic cyclophosphamide is based on previous experimental studies which has shown that it removes CD4+CD25+regulatory T cells preserving T and NK/T cell funtions.

Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarfilzomibDrug

    Also called Kyprolis

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

  • CyclophosphamideDrug

    Also called Alkyloxan

    50 mg PO days 1 to 21, every 4 weeks

  • DexamethasoneDrug

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

Study groups in NCT05909826
Study groupRoleWhat they receive
Weekly carfilzomib-oral cyclophosphamide-dexamethasoneExperimentalWeekly carfilzomib-oral cyclophosphamide-dexamethasone
Receives: Drug: Carfilzomib; Drug: Cyclophosphamide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Very good partial response

    Reduction of serum M-protein > 90%

    Measured: from the first date of KCd to the day 30 after KCd stop date

Secondary outcomes (6)

  1. Overall response

    sCR+CR+VGPR+PR

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

  5. Time to response

    the time from the first date of KCd to the first date of partial response

    Measured: from the first date of KCd to the date of first date of equal or more than partial response, which ever came first, assessed up to 48 months

  6. Safety profile

    Adverse events after KCd

    Measured: from the first date of KCd to day 30 after KCd stop date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05909826
Sponsor's protocol ID
DAUHIRB-23-038
Acronym
KMM-KCd
Status last verified
Jun 2023
First submitted
28 Feb 2023
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carfilzomib, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Dong-A University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ji Hyun Lee, MD, Ph.D (82-51-240-2915, hidrleejh@dau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Very good partial response (time frame: from the first date of KCd to the day 30 after KCd stop date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05909826.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.

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