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Phase II Study of Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Phase II Study of Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma


Inclusion Criteria:



- Participants must meet all of the following inclusion criteria to be eligible to
enroll in this study.

- Patients meeting the criteria for symptomatic multiple myeloma that has relapsed or
is refractory to at least 2 prior lines of therapy.

- Previous therapy with bortezomib.

- Previous therapy with thalidomide or lenalidomide.

- Patients must have measurable disease and therefore must have at least one of the
following:

Serum M-protein ≥1 gm/dL (≥10 gm/L) Urine M-protein ≥200 mg/24 hr Serum FLC assay:
involved FLC ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.

- Age ≥ 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Adequate hepatic
function, with serum ALT ≤ 3.5 times the upper limit of normal and serum direct
bilirubin ≤ 2 mg/dL (34 µmol/L) within 14 days prior to enrollment

- Absolute neutrophil count (ANC) ≥ 1.0 × 109/L within 14 days prior to enrollment
Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior to enrollment (participants may be
receiving red blood cell [RBC] transfusions in accordance with institutional
guidelines)

- Platelet count ≥ 50 × 109/L (≥ 30 × 109/L if thought to be secondary to myeloma
involvement of the bone marrow ) within 14 days prior to enrollment (platelet
transfusions are allowed)

- Creatinine clearance (CrCl) ≥ 15 mL/minute within 14 days prior to enrollment, either
estimated or calculated using a standard formula (eg, Cockcroft and Gault)

- Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and
to practice contraception.

- Male participants must agree to practice contraception.

Exclusion Criteria:

- Prior treatment with carfilzomib.

- Known CNS involvement with myeloma

- Pregnant or lactating females

- Major surgery within 21 days prior to registration.

- Acute active infection requiring treatment (systemic antibiotics, antivirals, or
antifungals) within 7 days prior to enrollment

- Known human immunodeficiency virus infection

- Active hepatitis B or C infection

- Unstable angina or myocardial infarction within 4 months prior to enrollment, NYHA
Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia
or Grade 3 conduction system abnormalities unless participant has a pacemaker

- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to
enrollment.

- Concurrent malignancies, except for treated non-melanoma skin cancer and cervical
carcinoma in situ.

- Significant neuropathy (Grades 3-4, ) within 14 days prior to enrollment

- Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize
carfilzomib)

- Contraindication to any of the required concomitant drugs or supportive treatments,
including options, antiviral drugs, or intolerance to hydration due to preexisting
pulmonary or cardiac impairment

- Concurrent therapy with any other anticancer therapeutic with activity against
multiple myeloma

- Concurrent therapy with investigative agents (e.g., antibiotics or antiemetics)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the best Overall Response Rate (ORR)

Outcome Description:

Defined as stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) to four cycles of infusional carfilzomib with or without dexamethasone in patients with multiple myeloma (MM) meeting eligibility criteria.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Nikoletta Lendvai, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

10-228

NCT ID:

NCT01351623

Start Date:

May 2011

Completion Date:

May 2013

Related Keywords:

  • Multiple Myeloma
  • PR-171 (CARFILZOMIB)
  • Chemotherapy
  • 10-228
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021