A study of Ibrutinib in Combination with Bortezomib and Dexamethasone in Multiple Myeloma Patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 125

Inclusion Criteria

1. Subjects with MM who have received 1-3 prior lines of therapy and have demonstrated disease progression since the completion of the most recent treatment regimen.
2. Measurable disease defined by at least ONE of the following:
• Serum monoclonal protein (SPEP) =1 g/dL
• Urine monoclonal protein (UPEP) =200 mg by 24 hour urine electrophoresis
3. Adequate hematologic function
4. Adequate hepatic and renal function
5. Prothrombin time (PT)/ International normal ratio (INR) =1.5 x upper limit of normal (ULN)
and PTT (activated partial thromboplastin time [aPTT]) =1.5 x ULN
6. Male and female =18 years of age
7. Eastern Cooperative Oncology Group (ECOG) performance status of =2.
8. Male and female subjects of reproductive potential who agree to use highly effective methods of birth control during the period of therapy and for 90 days after the last dose of study treatment. Female subjects who are of non-reproductive potential. Female subjects of reproductive potential must have a negative serum pregnancy test upon study entry.
Other protocol-defined inclusion criteria could apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Primary refractory disease defined as nonresponsive in patients who have never achieved a minimal response or better with any therapy.
2. History of plasma cell leukemia, primary amyloidosis, POEMS syndrome within 12 months prior to first administration of study treatment.
3. Recent prior chemotherapy
4. Prior exposure to BTK inhibitors
5. Refractory or non-responsive to prior PI therapy (bortezomib or carfilzomib)
6. History of hypersensitivity reactions to prior bortezomib, to boron, mannitol or nitrogen.
7. History of other malignancies
8. Peripheral neuropathy Grade =2 or Grade 1 with pain at Screening
9. Prior allogeneic stem cell transplant
10. Recent infection requiring systemic treatment that was completed <7 days before the first administration of study treatment and/or uncontrolled active
systemic infection.
11. Unresolved toxicities from prior anti-cancer therapy
12. Known bleeding disorders (eg, von Willebrand’s disease or hemophilia)
13. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
14. Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV)
15. Major surgery within 4 weeks of first administration of study treatment.
16. Any life-threatening illness, medical condition, including uncontrolled Diabetes Mellitus, or organ system dysfunction
17. Currently active, clinically significant hepatic impairment
18. Currently active, clinically significant cardiovascular disease
19. Unable to swallow capsules or malabsorption syndrome
20. Subjects who received a strong cytochrome P (CYP) 450 3A inhibitor within 7 days prior to the first administration of study treatment or subjects who require continuous treatment with a strong CYP 3A
inhibitor
21. Lactating or pregnant
Other protocol-defined exclusion criteria could apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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