Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for RRMM

NCT05909826 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DAUHIRB-23-038
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Outcome Measures

Primary Outcomes (1)

• Very good partial response

  Reduction of serum M-protein \> 90%

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

Secondary Outcomes (6)

• Overall response

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

• Progression-free survival

  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

• Overall survival

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

• Duration of response

  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

• Time to response

  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

Study Arms (1)

Weekly carfilzomib-oral cyclophosphamide-dexamethasone

EXPERIMENTAL

Weekly carfilzomib-oral cyclophosphamide-dexamethasone

Drug: Carfilzomib; Drug: Cyclophosphamide; Drug: Dexamethasone

Interventions

Carfilzomib DRUG

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

Also known as: Kyprolis

Weekly carfilzomib-oral cyclophosphamide-dexamethasone

Cyclophosphamide DRUG

50 mg PO days 1 to 21, every 4 weeks

Also known as: Alkyloxan

Weekly carfilzomib-oral cyclophosphamide-dexamethasone

Dexamethasone DRUG

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

Weekly carfilzomib-oral cyclophosphamide-dexamethasone

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• h 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

You may not qualify if:

• \. Subjects who were previously exposed to carfilzomib
• \. 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
• lead EKG : baseline ATcF \> 470msec
• D 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

Sponsors & Collaborators

• Dong-A University Hospital: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib; Cyclophosphamide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Sung-Hyun Kim, MD, Ph.D

  Dong-A University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Hyun Lee, MD, Ph.D

CONTACT

82-51-240-2915; hidrleejh@dau.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share