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Carfilzomib, Cyclophosphamide and Dexamethasone In Newly Diagnosed Multiple Myeloma Patients (CCD)

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: NCT01346787
Recruitment Status : Active, not recruiting
First Posted : May 3, 2011
Last Update Posted : March 25, 2022
Fondazione EMN Italy Onlus
Information provided by (Responsible Party):
European Myeloma Network

Brief Summary:
The purpose of this study is to determine whether the association of Carfilzomib, Cyclophosphamide and Dexamethasone (CCd) as induction treatment is safe and provides benefits in patients with newly diagnosed Multiple Myeloma (MM).

Condition or disease Intervention/treatment Phase

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 2011
Actual Primary Completion Date : October 2012
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: Carfilzomib Cyclophosphamide Dexamethasone
The treatment period includes administration of Carfilzomib Cyclophosphamide Dexamethasone for 9 courses. In order to assess the toxicity of treatment, patients will attend the study centre visits at each scheduled carfilzomib administration. The response will be assessed after each cycle.
Patients will start induction treatment with Cyclophosphamide given orally at the dose of 300 mg/m2 on days 1, 8, 15. Low dose Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15, 22 or 20 mg on days 1-2, 8-9,15-16, 22-23. Carfilzomib = 20 mg/m2 IV once daily on days 1, 2, of cycle 1 only followed by 36 mg/ m2 days 8, 9, 15, 16 in cycle 1, then for all subsequent doses 36 mg/ m2 IV once daily on days 1, 2, 8, 9, 15, 16, followed by 13-day rest period (day 17 through 28). Each cycle will be repeated every 28 days for a total of 9 courses. MANTEINANCE PERIOD At the end of induction phase (9 courses), maintenance phase with Carfilzomib alone IV at 36 mg/ m2 IV on days 1, 2, 15, 16 will start, until progression or intolerance. For patients who show evidence of progression during maintenance phase, the frequency of Carfilzomib can be increased to days 1, 2, 8, 9, 15, 16 at the discretion of the investigator, or the patient may be removed from the study

Primary Outcome Measures :
  1. Toxicity: Assessment of adverse events will be performed at the end of third cycle according to the National Cancer Institute Common Terminology Criteria of Adverse Events (CTCAE version 4.0) [ Time Frame: 4 years ]
    Toxicity is defined as the first occurrence of a grade 4 hematologic drug-related toxicity excluding anemia, (grade 4 neutropenia must last longer than 3 days and grade 4 thrombocytopenia must last longer than 7 days in order to be considered a toxicity) with the exception of (grade 4 neutropenia > 3 days , or grade 4 thrombocytopenia >7 days duration) or grade 3 non-hematologic drug-related toxicity.

  2. Efficacy will be assessed by considering partial response (PR) following the proposed regimen. Assessment of Partial Response rate will be performed at the end of third cycle according to the criteria of the International Myeloma Working Group. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 4 years ]
  2. Duration of Progression Free Survival [ Time Frame: 4 years ]
  3. Time to progression (TTP) [ Time Frame: 4 years ]
  4. Duration of Response (DOR) [ Time Frame: 4 years ]
  5. Duration of Overall Survival [ Time Frame: 4 years ]
  6. Time to next therapy [ Time Frame: 4 years ]
  7. Progressio Free Survival [ Time Frame: 4 years ]
    Relation between responses and Progression Free Survival, in responding and non-responding patients.

  8. β2-microglobulin as prognostic factors [ Time Frame: 4 years ]
    Subgroups analysis on prognostic factors

  9. peripheral neuropathy [ Time Frame: 4 years ]
    Rates of peripheral neuropathy, according to the National Cancer Institute Common Toxicity Criteria (version 4.0)

  10. Progression Free Survival [ Time Frame: 4 years ]
    Effect on Progression Free Survival of maintenance with low dose of Carfilzomib (days 1 and 2 every other week)

  11. C reactive protein as prognostic factors [ Time Frame: 4 years ]
    Subgroups analysis on prognostic factors

  12. cytogenetics as prognostic factors [ Time Frame: 4 years ]
    Subgroups analysis on prognostic factors

  13. microRNA [ Time Frame: 4 years ]
    Subgroups analysis on prognostic factors

  14. gene expression profile [ Time Frame: 4 years ]
    Subgroups analysis on prognostic factors

  15. Overall Survival [ Time Frame: 4 years ]
    Effect on Overall Survival of maintenance with low dose of Carfilzomib (days 1 and 2 every other week)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is of a legally consenting age as defined by local regulations.
  • Patient is age ≥ 65 year of age or who are ineligible for autologous stem cell transplantation.
  • 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 willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
  • Patient is a newly diagnosed MM patient.
  • Patient has measurable disease, defined as follows: any quantifiable serum monoclonal 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 >3 months.
  • Patient has the following laboratory values within 14 days before Baseline (day

    1 of the Cycle 1, before study drug administration):

  • Platelet count ≥50 x 109/L (≥30 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/minute

Exclusion Criteria:

  • - Patients with non-secretory MM, unless serum free light chains are present and the ratio is abnormal.
  • Pregnant or lactating females
  • Patient has active infectious hepatitis type B or C or HIV.
  • Patients with myocardial infarction or unstable angina ≤ 4 months or other clinically significant heart disease (e.g., CHF NY Heart Association class III or IV, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
  • Peripheral neuropathy > CTCAE grade 2 and ≥ grade 2 painful peripheral neuropathy (with the difference being in the exclusion of patients with Grade 2 painful PN).
  • Known history of allergy to Capsidol (a cyclodextrin derivative used to solubilize carfilzomib)
  • Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
  • Subjects 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.
  • Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, 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): NCT01346787

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IRCCS CROB UOC di Ematologia e trapianto cellule staminali Ospedale Oncologico Regionale
Rionero In Vulture, PZ, Italy, 85100
azienda ospedaliero-universitaria umberto I Clinica di Ematologia
Ancona, Italy, 60020
Policlinico S. Orsola Istituto di Ematologia e Oncologia Medica
Bologna, Italy, 40138
Ospedale Ferrarotto_Reparto di Ematologia
Catania, Italy, 95124
Az.Osp. Di Careggi_Dh ematologia
Firenze, Italy, 50134
Istituto Nazionale per lo Studio e la Cura dei Tumori_UO Ematologia_Trapianto di Midollo Osseo Allogenico
Milano, Italy, 20133
Divisione di Ematologia Dipartimento di Medicina Clinica e Sperimentale Università Amedeo Avogadro
Novara, Italy, 28100
Cattedra di ematologia Università La Sapienza
Roma, Italy
Divisione di Ematologia Ospedale S. Eugenio
Roma, Italy
S.C.di Oncoematologia, Azienda Ospedaliera S. Maria di Terni
Terni, Italy
SC Ematologia - A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy, 10126
Torino, Italy, 10126
Erasmus MC
Rotterdam, Netherlands
Sponsors and Collaborators
European Myeloma Network
Fondazione EMN Italy Onlus
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: European Myeloma Network Identifier: NCT01346787    
Other Study ID Numbers: IST-CAR-506
First Posted: May 3, 2011    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Keywords provided by European Myeloma Network:
multiple myeloma
newly diagnosed
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