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Multiple MyelomaPhase 1/2NCT01792102

Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Progressive Multiple Myeloma

A Phase 1/2 study testing Carfilzomib and Dexamethasone in people with Multiple Myeloma, run by Oncotherapeutics at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib for patients with progressive multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Carfilzomib and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
2 sitesUnited States
Study dates
Apr 2013to Dec 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

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

Who may be able to join

  • MM with relapsing or progressive disease at study entry
  • Defined as progressive MM on patient's last treatment regimen
  • Measurable disease, as defined by one or more of the following (assessed within 14 days prior to first dose):
  • Serum M-protein ≥ 0.5 g/dL, or
  • Urine M-protein ≥ 200 mg/24 hours, or
  • Only in patients who do not meet a or b, then use serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa/lamda ratio
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  • Age ≥ 18 years
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Adequate hepatic function within 14 days prior to first dose, with bilirubin < 1.5 × the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 × ULN
  • LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
  • Absolute neutrophil count (ANC) ≥ 1000/mm3 within 14 days prior to first dose. Screening ANC is to be independent of granulocyte colony stimulating factor support for ≥ 1 week and pegylated granulocyte colony stimulating factor for ≥ 2 weeks.
  • Hemoglobin ≥ 8.0 g/dL within 14 days prior to enrollment. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed.
  • Platelet count ≥ 75,000/mm3 (≥ 50,000/mm^3 if myeloma involvement in the bone marrow is > 50%) within 14 days prior to first dose. Patients must not have received platelet transfusions for at least 7 days prior to obtaining the screening platelet count
  • Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 14 days prior to first dose. Calculation are based on a standard formula, such as the Cockcroft and Gault: [(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female
  • Written informed consent in accordance with federal, local, and institutional guidelines
  • Female patients of childbearing potential (FCBP) must have a negative serum pregnancy test within 14 days prior to first dose and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). Postmenopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from a pregnancy test
  • Male patients must agree to use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP

Who cannot join

  • Multiple myeloma of IgM subtype
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
  • Waldenström's macroglobulinemia
  • Amyloidosis
  • Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to first dose
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  • Cytotoxic chemotherapy with approved or investigational anticancer therapeutics within 28 days prior to first dose
  • Treatment with bortezomib, thalidomide or lenalidomide within 21 days prior to first dose
  • Focal radiation therapy within 7 days prior to first dose. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (i.e., prior radiation must have been to < 30% of the bone marrow)
  • Immunotherapy within 21 days prior to first dose
  • Major surgery within 21 days prior to first dose
  • Active congestive heart failure (New York Heart Association [NYHA] Classes III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to first dose.
  • Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at HBV), or antifungal agents within 14 days prior to first dose
  • Known human immunodeficiency virus (HIV) seropositivity
  • Known hepatitis B or C virus infection (except for patients with HBV receiving and responding to HBV antiviral therapy: these patients are allowed)
  • Patients with known cirrhosis
  • Second malignancy within the past 3 years, except:
  • Adequately treated basal cell or squamous cell skin cancer
  • Carcinoma in situ of the cervix
  • Prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
  • Breast carcinoma in situ with full surgical resection
  • Treated medullary or papillary thyroid cancer
  • Patients with myelodysplastic syndrome
  • Significant neuropathy (Grades 3 to 4) within 14 days prior to first dose
  • Peripheral neuropathy with pain ≥ G2 within 14 days prior to first dose
  • Female patients who are pregnant or lactating
  • Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
  • Prior carfilzomib treatment
  • Prior participation in any Onyx-sponsored phase 3 trial
  • Patients with contraindication to dexamethasone
  • Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
  • Ongoing graft-versus-host disease
  • Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment
  • Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
  • Any other clinically significant medical disease or psychiatric condition that, in the Investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • John Theuer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • James R. Berenson M.D. Inc.

    West Hollywood, California, 90069

Other trials in United States

About this study

Official title: A Phase 1/2 Study of Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Patients With Progressive Multiple Myeloma

This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib for patients with progressive multiple myeloma.

Read the detailed description

This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib for patients with progressive multiple myeloma.

The study will consist of a screening period, followed by a treatment period of up to eight 28-day treatment cycles, followed by a period of maintenance treatment. Subjects are to be treated until disease progression.

Being tested
Carfilzomib and Dexamethasone
Keywords
Multiple Myeloma, Carfilzomib, Krypolis, 60 minute infusion
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Carfilzomib and DexamethasoneDrug

    Also called Krypolis®

    Phase 1: Carfilzomib will be administered at an escalating dose by cohort as 60-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. On Cycle 1 Days 1 and 2, carfilzomib will be given at 20 mg/m^2. For all subsequent doses, carfilzomib will be administered at the dose assigned to the cohort (56, 70, or 88 mg/m^2). Dexamethasone (8 mg IV or PO) will be administered prior to carfilzomib on Days 1, 2, 8, 9, 15, and 16.

    Phase 2: Carfilzomib will be administered at the MTD determined in phase 1. Maintenance: From Cycle 9 onward, carfilzomib and dexamethasone will be administered in the same fashion as during the previous treatment cycle, but only on days 1, 2, 15, and 16.

Study groups in NCT01792102
Study groupRoleWhat they receive
Carfilzomib and DexamethasoneExperimentalPhase 1: Carfilzomib will be administered at an escalating dose with dexamethasone administered at 8mg. Phase 2: Carfilzomib will be administered at the MTD determined in phase 1. Maintenance: Carfilzomib and dexamethasone will be administered in the same fashion as the previous treatment cycles, but only on days 1, 2, 15, and 16.
Receives: Drug: Carfilzomib and Dexamethasone

What is being measured

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

  1. Establish maximum tolerated dose (MTD)

    Maximum tolerated dose will be established by the number of dose limiting toxicities and the overall safety and tolerability of the study drug.

    Safety and tolerability will be determined by the following:

    1. incidence and frequency of adverse events throughout the study
    2. clinical laboratory test results at study visits
    3. vital signs measurements at each study visits
    4. medical history and physical examination findings
    5. ECOG performance status at study visits
    6. concomitant medication usage throughout the study

    Measured: monthly, up to 24 months

Secondary outcomes (1)

  1. Establish efficacy as assessed by the overall response rate

    Response rate will be determined by the following:

    1. SPEP, UPEP, and quantification of immunoglobulins and immunofixation
    2. bone marrow aspirates and biopsies to confirm CR
    3. roentgenographic skeletal survey

    Response rate will be assessed by the following:

    1. Clinical benefit response rate
    2. Progression-free survival
    3. Time to progression
    4. Duration of response
    5. Overall survival
    6. Pharmacodynamics

    Measured: monthly, up to 24 months

Timeline

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

  1. First posted15 Feb 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01792102
Sponsor's protocol ID
IST-CAR-585
Status last verified
Mar 2018
First submitted
3 Jan 2013
Last updated
5 Mar 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Carfilzomib and Dexamethasone in people with Multiple Myeloma, run by Oncotherapeutics at 2 sites in United States.

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 18 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establish maximum tolerated dose (MTD) (time frame: monthly, up to 24 months). 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 NCT01792102.

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 5 Mar 2018.

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