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NCT05909826Not yet recruitingPhase 2

Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for RRMM

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
49 (estimated)
First submitted
28 Feb 2023
Start date
1 Jul 2023
Primary completion date
30 Jun 2027
Lead sponsor
Dong-A University Hospital
NCT number
NCT05909826

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 49
  • From 1 Jul 2023 to the primary completion date, 30 Jun 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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,

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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
  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.