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Trial record 1 of 1 for:    NCT01660750
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A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma (11-MM-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01660750
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : October 18, 2017
Information provided by (Responsible Party):
Criterium, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Carfilzomib Drug: Cyclophosphamide Drug: Dexamethasone Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Carfilzomib, Cyclophosphamide, Dexamethasone
All eligible subjects will receive Carfilzomib, Cyclophosphamide, and Dexamethasone.
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

Primary Outcome Measures :
  1. Adverse Events as a measure of safety and tolerability [ Time Frame: Throughout treatment, estimated to be 4-6 months per patients ]
    Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.

Secondary Outcome Measures :
  1. Overall Response after induction therapy [ Time Frame: Every 28 days during induction therapy, estimated to be 4-6 months ]
    Overall response (PR, VGPR, CR, sCR)

  2. Overall Response post ASCT [ Time Frame: 3 and 6 months post ASCT ]
    Overall Response (PR, VGPR, CR, sCR) at 3 and 6 months post ASCT.

  3. Time to Progression [ Time Frame: Througout treatment and 3 and 6 months post ASCT ]
    Time to progression will be noted if it occurs within 6 months post ASCT.

  4. Progression Free Survival [ Time Frame: up to 6 months post ASCT ]
  5. Time to Next Therapy [ Time Frame: up to 6 months post ASCT ]
    Time to Next Therapy if occurs within 6 months post ASCT

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01660750

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United States, California
Samuel Oschin Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
United States, Massachusetts
University of Massachusettes Memorial
Worcester, Massachusetts, United States, 01655
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Criterium, Inc.
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Principal Investigator: Jatin Shah, MD AMyC
Principal Investigator: Brian GM Durie, MD AMyC
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Responsible Party: Criterium, Inc. Identifier: NCT01660750    
Other Study ID Numbers: AMyC 11-MM-01
CAR-IST-520 ( Other Identifier: Onyx Pharmaceuticals )
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Criterium, Inc.:
newly diagnosed multiple myeloma
transplant eligible multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents