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Carfilzomib In Combination With Bendamustine And Dexamethasone In Refractory Or Relapsed Multiple Myeloma

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: NCT02056756
Recruitment Status : Active, not recruiting
First Posted : February 6, 2014
Last Update Posted : August 2, 2018
Fondazione EMN Italy Onlus
Information provided by (Responsible Party):
Stichting Hemato-Oncologie voor Volwassenen Nederland

Brief Summary:

Open-label phase Ib/II, multicenter, international non-comparative trial. This study is designed to determine the safety and efficacy of the novel salvage regimen (CBd) followed by a carfilzomib maintenance in patients with relapsed or refractory multiple myeloma.

Patients will be evaluated at scheduled visits in up to 4 study periods:

pretreatment, treatment, maintenance and long-term follow-up (LTFU).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Carfilzomib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 2014
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Carfilzomib

Arm Intervention/treatment
Experimental: CBD Drug: Carfilzomib
Other Name: Krypolis

Primary Outcome Measures :
  1. Identification of dose-limiting toxicity (DLT) [ Time Frame: 1 year ]

    DLTs are defined as the following:

    • Any CTCAE grade ≥3 non-hematologic event except the following:

      1. Nausea or vomiting that responds symptomatic therapy.

    • Grade 4 neutropenia lasting more than 7 days.
    • Grade 4 hematologic toxicity except neutropenia
    • Development of febrile neutropenia defined as grade 3-4 neutropenia with fever 38.5°C and/or infection requiring antibiotic or antifungal treatment. Assessment of DLT defining adverse events will be performed after completion of the second cycle (only in phase Ib) according to the National Cancer Institute Common Terminology Criteria of Adverse Events (CTCAE version 4.0). Efficacy will be assessed by considering VGPR following the proposed regimen, according to the criteria of the International Myeloma Working Group

Secondary Outcome Measures :
  1. Determine the rate of very good partial response (VGPR) or more with the CBd association: [ Time Frame: 1 year ]
    Determine the rate of very good partial response (VGPR) or more with the CBd association: a VGPR rate of 20% (p0) is considered not promising (H0) and a 40% (p1) as interesting (phase II).

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:

  • Patient ≥ 18 years old.

    • Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
    • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
    • Female patient is either post-menopausal or surgically sterilized or commits continued abstinence from heterosexual intercourse during the duration of the study or is willing to use two methods of birth control, one highly effective method and one additional effective method at the same time, at least 4 weeks before starting carfilzomib and bendamustine therapy, during carfilzomib and bendamustine therapy and for at least 4 weeks after stopping carfilzomib and bendamustine therapy. Highly effective methods are hormonal contraceptives (birth control pills, injections, and implants), intrauterine device, tubal ligation and partner's vasectomy. Additional effective methods are condom, diaphragm, and cervical cap. Women with child bearing potential must have two negative pregnancy tests (sensitivity at least 50 mIU/mL) prior starting carfilzomib and bendamustine therapy. The first pregnancy test must be performed 10 - 14 days and the second within 24 hours before starting carfilzomib and bendamustine therapy. Pregnancy testing for the first 4 weeks of study therapy must be performed weekly and thereafter every 4 weeks if menstrual cycles are regular or every 2 weeks if menstrual cycles are irregular.
    • Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study and for 6 months after stopping study therapy.
    • Patient with relapsed or/and refractory multiple myeloma after failure of two or more treatment regimens (previous bortezomib is allowed).
    • Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein (M-protein) value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo- or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results.
    • Patient has a Karnofsky performance status ≥60%.
    • Patient has a life expectancy >6 months.
    • Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1, before study drug administration):
  • Platelet count ≥70 x 109/L (≥50 x 109 /L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to drug administration).
  • Absolute neutrophil count (ANC) ≥ 1 x 109/L without the use of growth factors.
  • Corrected serum calcium ≤14 mg/dL (3.5 mmol/L).
  • Alanine transaminase (ALT): ≤ 3 x the ULN.
  • Total bilirubin: ≤ 2 x the ULN.
  • Calculated or measured creatinine clearance ≥ 15 mL/min (or, as alternative serum creatinine <2 mg/dL).
  • LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available (not applicable in Germany).

Exclusion Criteria:

  • Pregnant or lactating females

    • Patient has active infectious hepatitis type B or C or HIV.
    • Patients with active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
    • Peripheral neuropathy (PN) > CTCAE grade 2 and ≥ grade 2 painful PN (with the difference being in the exclusion of patients with Grade 2 painful PN).
    • Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
    • Known history of intolerability to high dose dexamethasone
    • Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and anti-platelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
    • Subject with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to baseline;
    • Patient has any other clinically significant illness that would, in the investigator's opinion, increase the patient's risk for toxicity.
    • Patient with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma of the skin, or in situ cancer of the cervix or breast, or localized prostate cancer of Gleason score <7 with a stable PSA).

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): NCT02056756

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Universitätsklinikum Schleswig-Holstein (UKSH) - Division of Stem Cell Transplantation and Immunotherapy, 2nd Department of Medicine
Kiel, Germany, 24105
Fo.NE.Sa. Onlus
Torino, TO, Italy, 10126
Divisione di Ematologia A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona
Ancona, Italy, 60126
Sponsors and Collaborators
Stichting Hemato-Oncologie voor Volwassenen Nederland
Fondazione EMN Italy Onlus
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Responsible Party: Stichting Hemato-Oncologie voor Volwassenen Nederland Identifier: NCT02056756    
Other Study ID Numbers: EMN09
2012-003938-17 ( EudraCT Number )
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Keywords provided by Stichting Hemato-Oncologie voor Volwassenen Nederland:
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