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A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma (11-MM-01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Academic Myeloma Consortium
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by (Responsible Party):
Academic Myeloma Consortium
ClinicalTrials.gov Identifier:
NCT01660750
First received: August 7, 2012
Last updated: May 22, 2014
Last verified: May 2014

August 7, 2012
May 22, 2014
January 2013
November 2014   (final data collection date for primary outcome measure)
Adverse Events as a measure of safety and tolerability [ Time Frame: Throughout treatment, estimated to be 4-6 months per patients ] [ Designated as safety issue: Yes ]
Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.
Same as current
Complete list of historical versions of study NCT01660750 on ClinicalTrials.gov Archive Site
  • Overall Response after induction therapy [ Time Frame: Every 28 days during induction therapy, estimated to be 4-6 months ] [ Designated as safety issue: No ]
    Overall response (PR, VGPR, CR, sCR)
  • Overall Response post ASCT [ Time Frame: 3 and 6 months post ASCT ] [ Designated as safety issue: No ]
    Overall Response (PR, VGPR, CR, sCR) at 3 and 6 months post ASCT.
  • Time to Progression [ Time Frame: Througout treatment and 3 and 6 months post ASCT ] [ Designated as safety issue: No ]
    Time to progression will be noted if it occurs within 6 months post ASCT.
  • Progression Free Survival [ Time Frame: up to 6 months post ASCT ] [ Designated as safety issue: No ]
  • Time to Next Therapy [ Time Frame: up to 6 months post ASCT ] [ Designated as safety issue: No ]
    Time to Next Therapy if occurs within 6 months post ASCT
Same as current
Not Provided
Not Provided
 
A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma
A Multi-Center Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide With Dexamethasone Prior to ASCT in Patients With Transplant Eligible Newly Diagnosed Myeloma

This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant eligible multiple myeloma. The study will also explore the efficacy of Car-Cy-Dex including overall response after induction therapy, overall response at 3 and 6 months post ASCT, and time to progression, progression free survival, and time to next therapy if it occurs within 6 months post ASCT.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Carfilzomib
    IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
    Other Names:
    • PR-171
    • Kyprolis
  • Drug: Cyclophosphamide
    PO on days 1, 8, and 15 every 28 days
    Other Name: Cytoxan
  • Drug: Dexamethasone
    40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.
    Other Name: Decadron
Experimental: Carfilzomib, Cyclophosphamide, Dexamethasone
All eligible subjects will receive the study intervention of Carfilzomib, Cyclophosphamide, and Dexamethasone.
Interventions:
  • Drug: Carfilzomib
  • Drug: Cyclophosphamide
  • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
38
March 2015
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cytopathologically or histologically confirmed diagnosis of MM
  • Measurable disease, as indicated by one or more of the following:
  • Serum M-protein ≥ 1.0 g/dL
  • Urine Bence Jones protein ≥ 200 mg/24 hr
  • Elevated Free Light Chain as per the International Myeloma Working Group (IMWG) criteria
  • Males and females ≥ 18 years of age
  • Life expectancy of more than 5 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • Adequate hepatic function, with bilirubin < 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.5 times ULN
  • Serum Creatinine Clearance(CrCl) ≥ 30 mL/min, either measured or calculated using a standard formula (e.g. Cockcroft and Gault)
  • Additional Laboratory Requirements
  • Absolute neutrophil count (ANC) ≥1.0 x 109/L
  • Hemoglobin ≥8 g/dL [transfusion permitted]
  • Platelet count ≥50.0 x 109/L
  • Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
  • Patients may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines
  • Written informed consent in accordance with federal, local, and institutional guidelines
  • Patients must agree to practice contraception
  • Male patients must agree not to donate semen or sperm.

Exclusion Criteria:

  • Patients with non-secretory or hyposecretory MM
  • Prior treatment for MM (prior radiation therapy or dexamethasone up to 160 mg for spinal cord compression is allowed. Other limited field radiation involving ≤ 1/3 of the pelvic area is also allowed)
  • Plasma cell leukemia
  • Pregnant or lactating females
  • Major surgery within 21 days prior to first dose
  • Congestive heart failure (CHF) (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months
  • Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose
  • Patients receiving active treatment or intervention for any other malignancy or patients who, at the Investigator's discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment.
  • Serious psychiatric or medical conditions that could interfere with treatment
  • Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before study treatment
  • Contraindication to any of the required concomitant drugs, including antiviral (e.g. Valacyclovir) and proton-pump inhibitor (e.g. lansoprazole). Corticosteroid therapy in a dose equivalent to dexamethasone ≥ 1.5 mg/day or prednisone ≥ 10 mg/day. (Steroid use is allowed if necessary to treat spinal cord compression and/or hypocalcaemia.)
  • Patients in whom the required program of oral and IV fluid hydration is contraindicated, e.g. due to pre-existing pulmonary, cardiac, or renal impairment
  • Patients with primary systemic amyloidosis.
Both
18 Years and older
No
United States
 
NCT01660750
AMyC 11-MM-01, CAR-IST-520
No
Academic Myeloma Consortium
Academic Myeloma Consortium
Onyx Pharmaceuticals
Principal Investigator: Jatin Shah, MD Academic Myeloma Consortium
Principal Investigator: Brian GM Durie, MD Academic Myeloma Consortium
Academic Myeloma Consortium
May 2014

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