Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01351623
First received: May 9, 2011
Last updated: February 7, 2014
Last verified: February 2014

May 9, 2011
February 7, 2014
May 2011
May 2015   (final data collection date for primary outcome measure)
To evaluate the best Overall Response Rate (ORR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01351623 on ClinicalTrials.gov Archive Site
  • To evaluate the safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Toxicity scoring will be done using NCI CTCAE v4.0.
  • time to progression (TTP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Median TTP defined as the time from start of treatment to disease progression. Participants who do not have disease progression will be censored at their date of last response assessment or date of death.
  • duration of response (DOR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    DOR is defined as the time from first evidence of PR or better [first observation of PR before confirmation] to disease progression, with deaths owing to causes other than progression censored.
  • progression free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Rate of PFS defined as the time from start of treatment to disease progression or death. PFS will be calculated for all patients who have received at least one dose of carfilzomib. Median duration of PFS will be reported.
Same as current
Not Provided
Not Provided
 
Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma
Phase II Study of Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to test a new drug called carfilzomib. It is a type of drug called a proteasome inhibitor. Proteasome breaks down proteins that are no longer useful to the cell. When the proteasome is turned off by a drug (like carfilzomib), useless proteins cannot be broken down. Instead the proteins build up and cause the cell to die. Myeloma cells make a lot of protein and are especially in need of a functional proteasome to survive.

Carfilzomib is not approved for use by the Food and Drug Administration to treat myeloma. It is considered an experimental drug. Previous studies have shown that carfilzomib is safe to use. This study will look at what the effects, good and/or bad, carfilzomib has on myeloma.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: Carfilzomib
Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
Experimental: Carfilzomib
A single arm, open-label, single institution phase 2 clinical trial is planned.
Intervention: Drug: Carfilzomib
Lendvai N, Hilden P, Devlin S, Landau H, Hassoun H, Lesokhin AM, Tsakos I, Redling K, Koehne G, Chung DJ, Schaffer WL, Giralt SA. A phase 2 single-center study of carfilzomib 56 mg/m2 with or without low-dose dexamethasone in relapsed multiple myeloma. Blood. 2014 Aug 7;124(6):899-906. doi: 10.1182/blood-2014-02-556308. Epub 2014 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
44
May 2015
May 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01351623
10-228
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Onyx Pharmaceuticals
Principal Investigator: Nikoletta Lendvai, MD,PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP