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Trial record 72 of 308 for:    IBRUTINIB

Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02902965
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

Brief Summary:
This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Ibrutinib Drug: Bortezomib Drug: Dexamethasone Phase 2

Detailed Description:
Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoeitic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. Ibrutinib is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with bortezomib and dexamethasone in subjects with relapsed/relapsed and refractory multiple myeloma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
Actual Study Start Date : September 30, 2016
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : October 26, 2018


Arm Intervention/treatment
Experimental: Ibrutinib+ Bortezomib+ Dexamethasone Drug: Ibrutinib
Ibrutinib 840 mg orally, once daily continuously starting day 1 of cycle 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation
Other Name: Imbruvica

Drug: Bortezomib
Cycles 1-8: (21-day cycle): Bortezomib 1.3 mg/m^2 sub-cutaneously on days 1, 4, 8, and 11 of each Cycle Cycles 9-12: (42-day cycle): Bortezomib 1.3 mg/m^2 sub-cutaneously on days 1, 8, 22 and 29 of each Cycle
Other Name: Velcade

Drug: Dexamethasone

Cycles 1-8: (21-day cycle): Dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle Cycles 9-12: (42-day cycle): Dexamethasone 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each cycle Cycles 13+ (28-day cycle): Dexamethasone 40 mg orally once weekly

Dose adjustment of dexamethasone to 10 mg on days specified during cycles 1-12 and 20 mg weekly during cycles 13+ is recommended for subjects >75 years of age.





Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Three years ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Three years ]
  2. Progression Free Survival (PFS) at Landmark Points [ Time Frame: Three years ]
  3. Duration of Response (DOR) [ Time Frame: Three years ]
  4. Overall Survival (OS) [ Time Frame: Three years ]
  5. Time to Progression (TTP) [ Time Frame: Three years ]
  6. Safety and tolerability of ibrutinib in combination with bortezomib and dexamethasone as measured by the frequency and type of adverse events graded using the NCI CTCAE v 4.03 [ Time Frame: From the time of enrollment until the completion of the study, assessed up to 3 years ]
    Safety and tolerability of ibrutinib in combination with bortezomib and dexamethasone as measured by the frequency and type of adverse events graded using the NCI CTCAE v 4.03



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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:

  • Subjects with multiple myeloma (MM) who have received 1-3 prior lines of therapy and have demonstrated disease progression since the completion of the most recent treatment regimen. (Subjects may have received prior bortezomib exposure if it does not meet the exclusion criteria for prior proteasome inhibitor use)
  • Measurable disease defined by at least one of the following:

    • Serum monoclonal protein (SPEP) ≥1 g/dL (for subjects with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE) or immunoglobulin M (IgM) multiple myeloma SPEP ≥0.5 g/dL)
    • Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine electrophoresis
  • Adequate hematologic, hepatic and renal function
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

Exclusion Criteria:

  • Subject must not have primary refractory disease
  • Refractory or non-responsive to prior proteasome inhibitor (PI) therapy (bortezomib or carfilzomib)
  • Peripheral neuropathy Grade ≥2 or Grade 1 with pain at Screening
  • Plasma cell leukemia, primary amyloidosis, or POEMS syndrome
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function
  • Requires treatment with strong CYP3A inhibitors
  • Women who are pregnant or breast feeding

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): NCT02902965


Locations
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Czechia
Fakultní nemocnice Brno
Brno, Czechia
Fakultní nemocnice Hradec Králové
Nový Hradec Králové, Czechia
Fakultní nemocnice Ostrava
Ostrava-Poruba, Czechia
Všeobecná fakultní nemocnice v Praha
Praha 2, Czechia
Germany
Helios-Kliniken Berlin-Buch
Berlin, Germany
Vivantes Klinikum Spandau
Berlin, Germany
Universitätsklinikum Jena
Jena, Germany
Klinikum der Universität München Campus Grosshadern
München, Germany
Greece
251 General Air Force Hospital
Athens, Greece
General Hospital of Athens "Alexandra"
Athens, Greece
General Hospital of Athens "Evangelismos"
Athens, Greece
General Hospital of Athens "LAIKO"
Athens, Greece
University General Hospital of Patra
Patras, Greece
General Hospital of Thessaloniki "G. Papanikolau"
Thessaloniki, Greece
Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Italy
Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori
Meldola (FC), Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Ospedale degli Infermi
Rimini, Italy
Azienda Ospedaliera S. Maria di Terni
Terni, Italy
Spain
Hospital Universitario Rey Juan Carlos
Mostoles, Madrid, Spain
Complejo Hospitalario Universitario A Coruña
A Coruna, Spain
ICO Badalona-Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Turkey
Ankara University Medical Faculty
Ankara, Turkey
Dokuz Eylul University Medicine Faculty
Izmir, Turkey
Erciyes University Medical Faculty
Kayseri, Turkey
Ondokuz Mayis Univ. Med. Fac.
Samsun, Turkey
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
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Study Director: Edyta Dobkowska, MD Pharmacyclics LLC.

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Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02902965     History of Changes
Other Study ID Numbers: PCYC-1139-CA
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pharmacyclics LLC.:
Bruton's Tyrosine Kinase
Bortezomib
Dexamethasone
Ibrutinib

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
Bortezomib
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