Skip to content
Triangle logo TriangleGet started
← Study library

NCT03773107 · REGISTRY CONDITION SEARCH

LCI-HEM-MYE-CRD-004 (MMRC-073 CARJAK): Study of CRD for Carfilzomib-Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2025-01-13

The primary objective of Phase I is to establish the maximum tolerated dose (MTD) of ruxolitinib in combination with carfilzomib and dexamethasone. The primary objective of phase II is to evaluate progression-free survival (PFS) at 4 months in multiple myeloma subjects who receive the combination treatment carfilzomib, dexamethasone, and ruxolitinib.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Dose Limiting Toxicity (DLT)

→

outcome · POSTED

Objective Response Rate (ORR)

→

outcome · POSTED

Clinical Benefit Rate

→

outcome · POSTED

Disease Control Rate

→

outcome · POSTED

Progression-free Survival (PFS)

→

outcome · POSTED

Time to Best Response

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Time to Progression

→

outcome · POSTED

Duration of Response

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria Subjects must meet all of the following criteria: 1. Documented history of relapsed and/or refractory multiple myeloma with \> 2 lines of therapy. One of the prior lines of therapy must have been a carfilzomib containing regimen with evidence of relapse or progression within the last 60 days of the carfilzomib containing regimen with a carfilzomib dose of at least 27 mg/m2. Carfilzomib containing regimen at the standard dose of 20/27 mg/m2 is acceptable. 2. Measurable disease, as defined by at least one of the following: 1. Serum monoclonal protein level ≥0.5 g/dL for IgG, IgA, or IgM disease 2. Urinary M-protein excretion of ≥200 mg over a 24-hour period 3. Involved free light chain level ≥10 mg/dL, along with an abnormal free light chain ratio 3. Adequate bone marrow reserves, as defined by the following: 1. Absolute neutrophil count (ANC) ≥1000 cells/mm3 within 1 week of the initiation of treatment 2. Platelet count of ≥75 ,000 cells/mm3 for subjects who have bone marrow plasmacytosis of \<50%, or ≥50,000 cells/mm3 for subjects who have bone marrow plasmacytosis of \>50% 4. Adequate hepatic function, as defined by the following: 1. Total bilirubin ≤ 2 times the upper limit of the institutional normal values 2. Total AST and ALT ≤ 3 times the upper limit of the institutional normal values 5. Adequate renal function, as defined by the following: creatinine clearance (CrCl) ≥ 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula. 6. Adequate cardiac function defined as LVEF ≥ 40% by MUGA, echocardiogram or cardiac MRI. 7. Be 18-75 years of age 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 9. FOCBP and male subjects who are sexually active with FOCBP must agree to use two highly effective (as determined per the Investigator) methods of contraception during the study and for 30 days (female subjects) or for 90 days (male subjects) following the last dose of study treatment including a male condom. 10. Ability to understand and the willingness to sign a written informed consent document. 11. Recovered from all reversible acute toxic effects of prior therapy (other than alopecia) to ≤ Grade 1 or baseline. Exclusion Criteria Subjects must not meet any of the following criteria: 1. Non-secretory multiple myeloma 2. Known amyloidosis 3. Known POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 4. Clinically significant illness including, but not limited to the following: active systemic infection, uncontrolled hypertension (as defined by BP \> 160/90), New York Heart Association Class III and IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months of consent, uncontrolled cardiac arrhythmia, or any other condition (including laboratory abnormalities) that, in the opinion of the Investigator, places the subject at unacceptable risk for adverse outcome if he/she were to participate in the study 5. Prior cerebrovascular accident with persistent neurologic deficit. 6. Psychiatric illness/social situations that would limit compliance with study treatment and requirements 7. Pregnant or breast feeding. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test within the 7 days prior to study drug administration and a negative urine pregnancy test within the 3 days prior to the first study drug administration. 8. Known human immunodeficiency virus (HIV) infection 9. Active hepatitis B and/or hepatitis C infection 10. Currently active second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Subjects are not considered to have a currently active malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for \>5 years, and are considered by their physician to be at less than 30% risk of relapse. In addition, subjects with basal cell carcinoma of the skin, superficial carcinoma of the bladder, carcinoma of the prostate with a current PSA value of \<0.5 ng/mL, or cervical intraepithelial neoplasia will be eligible. Finally, subjects who are on hormonal therapy for a history of either prostate cancer or breast cancer may enroll, provided that there has been no evidence of disease progression during the previous three years. 11. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib). 12. Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or ascites requiring paracentesis. 13. Known intolerance to carfilzomib. 14. Co-administration with strong CYP3A4 inhibitors (such as, but not limited to, boceprevir, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole) as well as fluconazole (a dual inhibitor of CYP3A4 and CYP2C9).
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib
    intervention Names
    1. Drug: Carfilzomib
    2. Drug: Ruxolitinib
    3. Drug: Dexamethasone
    label
    Phase I
    type
    EXPERIMENTAL
  2. description
    Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen
    intervention Names
    1. Drug: Carfilzomib
    2. Drug: Ruxolitinib
    3. Drug: Dexamethasone
    label
    Phase II
    type
    OTHER
interventions
  1. arm Group Labels
    1. Phase I
    2. Phase II
    description
    Irreversible proteasome inhibitor
    name
    Carfilzomib
    other Names
    1. Kyprolis
    type
    DRUG
  2. arm Group Labels
    1. Phase I
    2. Phase II
    description
    Oral JAK inhibitor
    name
    Ruxolitinib
    other Names
    1. Jakafi
    type
    DRUG
  3. arm Group Labels
    1. Phase I
    2. Phase II
    description
    glucocorticoid
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
12
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    DLTs will be determined for each subject as a binary variable indicating whether or not the subject experienced a DLT during Cycle 1
    measure
    Dose Limiting Toxicity (DLT)
    time Frame
    28 days
secondary Outcomes
  1. description
    Objective response will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of PR or better as per the IMWG criteria
    measure
    Objective Response Rate (ORR)
    time Frame
    Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle)
  2. description
    Clinical benefit will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of minimal response (MR) or better as determined by the IMWG criteria
    measure
    Clinical Benefit Rate
    time Frame
    Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle)
  3. description
    Disease control will be determined for each subject as a binary variable indicating whether or not the subject achieved a disease response or stable disease for greater than or equal to 8 weeks
    measure
    Disease Control Rate
    time Frame
    Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle)
  4. description
    PFS is defined as the duration of time from the initiation of study treatment with ruxolitinib to first occurrence of either progressive disease or death without progressive disease.
    measure
    Progression-free Survival (PFS)
    time Frame
    approx. 5 years
  5. description
    Time to best response will be defined as the time from initiation of ruxolitinib treatment to the time of best objective status assessment of response.
    measure
    Time to Best Response
    time Frame
    Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle)
  6. description
    Overall survival is defined as the duration from initiation of ruxolitinib treatment to the date of death from any cause.
    measure
    Overall Survival
    time Frame
    approx. 5 years
  7. description
    Time to progression (TTP) is defined as the duration of time from the initiation of study treatment with ruxolitinib to first occurrence of either progressive disease or death.
    measure
    Time to Progression
    time Frame
    approx. 5 years
  8. description
    Duration of response will be defined as the time from first objective status assessment of response to the time of first documented disease progression or death.
    measure
    Duration of Response
    time Frame
    approx. 5 years
Full study description
brief Summary
The primary objective of Phase I is to establish the maximum tolerated dose (MTD) of ruxolitinib in combination with carfilzomib and dexamethasone. The primary objective of phase II is to evaluate progression-free survival (PFS) at 4 months in multiple myeloma subjects who receive the combination treatment carfilzomib, dexamethasone, and ruxolitinib.
detailed Description
This is an open-label, Phase I/II study of carfilzomib, ruxolitinib, and low-dose dexamethasone for carfilzomib-refractory multiple myeloma. Phase I is designed to evaluate overall maximum tolerated dose (MTD) of ruxolitinib in combination with carfilzomib and dexamethasone in the following cohorts: Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib. Phase II is designed to evaluate 4-month progression-free survival (PFS) in the following cohorts: Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen. Up to 18 evaluable subjects will be enrolled in Phase I over approximately 12 months. An additional 30 evaluable subjects will be enrolled in Phase II over 24 months.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a71ef65bc8255351993c
      requested nct id
      NCT03773107
      primary nct id
      NCT03773107
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      5f73fc33d7c11640ba81660121d4c461264f65c3f4b841d155d3d4509fcb2d64
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a71ef65bc8255351993c
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT03773107
      occurrences
      1. context exact
        NCT03773107
        end
        11
        exact text
        NCT03773107
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/181/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      77ce84252880404ca1358f3c5c2137a434e7e3f9604fcdda8a40fe9b3ca11224

    Preserved source evidence · Not medical advice