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Trial record 78 of 183 for:    carfilzomib OR pr-171

Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03336073
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Brief Summary:

This is a multicenter, open label, phase II randomized controlled study that will evaluate the efficacy of carfilzomib and dexamethasone in combination with cyclophosphamide in R/R MM patients.

For this purpose, R/R MM patients that have received 1-3 prior lines of therapy, and who are not primary refractory or refractory to proteasome inhibitors will be randomized to receive:

  • Experimental arm: carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, dexamethasone by mouth (po) at a dose of 20 mg (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16 and cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15, in 28 days cycles; or
  • Control arm: the same treatment but without cyclophosphamide. Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mg/m2 (20 mg/m2 only in the first infusion) during the cycles 1 and 2.

If tolerability is acceptable, the dose could be increased up to 70 mg/m2 since the cycle 3.

Treatment will be continued until progression, unacceptable toxicity or investigator or patient decision.


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

Detailed Description:

Treatment will consist of 28-days cycles with:

  • Arm 1 (experimental arm):

    • Carfilzomib administered iv at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) iv on days 1, 8 and 15.
    • Dexamethasone at a dose of 20 mg po (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16.
    • Cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15
  • Arm 2 (control arm):

    • Carfilzomib administered iv at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) iv on days 1, 8, and 15.
    • Dexamethasone at a dose of 20 mg po (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16.

Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mg/m2 (20 mg/m2 only in the first infusion) during the cycles 1 and 2.

If tolerability is acceptable, the dose could be increased up to 70 mg/m2 since the cycle 3.

Treatments will be administered until progressive disease (PD) or unacceptable toxicity. Carfilzomib and cyclophosphamide will be provided by the sponsor. Dexamethasone may be utilized per a site's standard practice and will not be provided by the sponsor.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carfilzomib and Dexamethasone in Combination With Cyclophosphamide vs. Carfilzomib and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma: a Phase II Randomized Controlled Trial
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: carfilzomib, dexamethasone and cyclophosphamide
carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, dexamethasone by mouth (po) at a dose of 20 mg (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16 and cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15, in 28 days cycles
Drug: Carfilzomib
carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15

Drug: Dexamethasone
dexamethasone oral at a dose of 20 mg (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16

Drug: cyclophosphamide
cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15

Active Comparator: carfilzomib and dexamethasone
carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, dexamethasone by mouth (po) at a dose of 20 mg (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16 , in 28 days cycles
Drug: Carfilzomib
carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15

Drug: Dexamethasone
dexamethasone oral at a dose of 20 mg (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16




Primary Outcome Measures :
  1. Efficacy of carfilzomib, dexamethasone and cyclophosphamide in number of responses obtiened [ Time Frame: 2 years ]
    Evaluate the efficacy of carfilzomib and dexamethasone in combination with cyclophosphamide in terms of response rate in multiple myeloma (MM) patients.


Secondary Outcome Measures :
  1. Safety of carfilzomib, dexamethasone and cyclophosphamide in Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
    the safety as determined by the incidence of clinical and laboratory toxicities



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
Criteria

Inclusion Criteria:

  • Primary refractory patients defined as not having achieved at least a partial response with a prior therapy.
  • Refractoriness to prior proteasome inhibitor therapies, defined as not having achieved at least MR or having progressed under treatment or in the first 60 days after the last dose of the proteasome inhibitor.
  • Adequate haematological or biochemical parameters as specified below:

    • Hemoglobin <8.0 g/dL.
    • Platelets count <75x109/L without previous platelet transfusions in the last 7 days. If high bone marrow infiltration (>50%) is present, ≥50x109/L platelet count is required.
    • Absolute neutrophil count (ANC) <0.75 x109/L without previous G-CSF support in the last 7 days.
    • Aspartate transaminase (AST): >2.5 x the upper limit range.
    • Alanine transaminase (ALT): >2.5 x the upper limit range.
    • Total bilirubin: >2 x the upper limit range.
    • Calculated or measured creatinine clearance: <30 mL/min (calculated from the Cockcroft and Gault formula)

Exclusion Criteria:

  • Left ventricular ejection fraction <50%.
  • Absence of recovery from any significant non-haematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade < 2 symptomatic peripheral neuropathy is allowed.
  • Pregnant or lactating women; men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception).
  • Previous history of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site).
  • Other relevant diseases or adverse clinical conditions: Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study; Uncontrolled arterial hypertension or cardiac arrhythmias (i.e. requiring a change in medication within the last 3 months or a hospital admission within the past 6 months); History of significant neurological or psychiatric disorders; Active infection; Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis);
  • Patient is known to be human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive or to suffer active hepatitis C infection.
  • Concomitant anti-myeloma therapy within 14 days prior to Day 1 of Cycle 1.
  • Limitation of the patient's ability to comply with the treatment or follow-up protocol.
  • Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).

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 ClinicalTrials.gov identifier (NCT number): NCT03336073


Contacts
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Contact: M Victoria Mateos, Dr 34 923 29 16 34 mvmateos@usal.es
Contact: Enrique M Ocio, Dr 34 923 29 16 34 emocio@usal.es

Locations
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Spain
Hospital Universitario de Canarias Recruiting
Tenerife, Islas Canarias, Spain
Contact: Hernández Miguel, Dr    + 34 922 67 80 00      
Principal Investigator: Hernández Miguel, Dr         
H.Universitari Germans Trias I Pujol de Badalona Recruiting
Barcelona, Spain
Contact: Albert Oriol, Dr       aoriol@iconcologia.net   
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain
Contact: Laura Rosiñol, Dr    + 34 93 2275400    LROSINOL@clinic.cat   
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Miguel Granell Gorrochategui, Dr    + 34 93 5565647    MGranell@santpau.cat   
Ico L'Hospitalet Recruiting
Barcelona, Spain
Contact: Anna Sureda, Dr       asureda@iconcologia.net   
Complejo Hospitalario de Cáceres Recruiting
Cáceres, Spain
Contact: M Carmen Cabrera, Dr    927 25 62 00      
Hospital de Cabueñes Recruiting
Gijón, Spain
Contact: María Esther González García    + 34 985 18 50 00      
Centro Hospitalario Universitario de Granada Recruiting
Granada, Spain
Contact: Rafael Ríos Tamayo, Dr    + 34 958 02 00 00    rafael.rios.sspa@juntadeandalucia.es   
Hospital de León Recruiting
León, Spain
Contact: Fernando Escalante Barrigón, Dr    + 34 987 23 74 00    fescalanteb@yahoo.es   
H. 12 de Octubre Recruiting
Madrid, Spain
Contact: Juan Jose Lahuerta, Dr    + 34 913 90 80 00    jjlahuerta@telefonica.net   
H. Ramón y Cajal Recruiting
Madrid, Spain
Contact: María Jesús Blanchard Rodríguez, Dr    + 34 913 36 80 00    mjesusblanchard@yahoo.es   
Hospital Sanchinarro Recruiting
Madrid, Spain
Contact: Jaime Pérez de Oteyza, Dr    + 34 902 08 98 00    jperezoteyza@hmhospitales.com   
Hospital Universitario Morales Meseguer Recruiting
Murcia, Spain
Contact: Felipe De Arriba, Dr    + 34 968 36 09 00    Farriba@um.es   
Hospital Virgn de la Arrixaca Recruiting
Murcia, Spain
Contact: María José Moreno Belmonte, Dr    + 34 968 36 95 00      
Hospital Costa del Sol Recruiting
Málaga, Spain
Contact: María Casanova Espinosa, Dr    + 34 951 97 66 69    mariacasanova@yahoo.com   
Hospital Central de Asturias Recruiting
Oviedo, Spain
Contact: Ana Pilar González Rodríguez, Dr    +34 985 108 000    anapilargonzalez@gmail.com   
Hospital de Son Llàtzer Recruiting
Palma De Mallorca, Spain
Contact: Joan Bargay, Dr    + 34 871 20 20 00    jbargay@hsll.es   
Clinica Universitaria de Navarra Recruiting
Pamplona, Spain
Contact: Paula Rodríguez Otero, Dr    + 34 948 25 54 00    paurodriguez@unav.es   
Hoapital Clinico Universitario Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Mª Victoria Mateos, Dr    + 34 923 29 11 00    mvmateos@usal.es   
Hospital Universitario de Santiago Recruiting
Santiago De Compostela, Spain
Contact: Marta Sonia González Pérez    + 34 981 95 00 00    marta.sonia.gonzalez.perez@sergas.es   
Hospital de Segovia Recruiting
Segovia, Spain
Contact: Aránzazu García Mateo, Dr    + 34 921 41 91 00      
Complejo Hospitalario Regional Virgen Del Rocío Recruiting
Sevilla, Spain
Contact: Jesús Martín, Dr       jesusms79@gmail.com   
Hospital de Toledo Recruiting
Toledo, Spain
Contact: Felipe Felipe Casado Montero, Dr    + 34 925 25 93 50      
Hospital Lozano Blesa Recruiting
Zaragoza, Spain
Contact: Victoria Dourdil Sahun, Dr    + 34 976 76 57 00      
Sponsors and Collaborators
PETHEMA Foundation

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Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT03336073     History of Changes
Other Study ID Numbers: GEM-KyCyDex
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors