Phase
Condition
Gliomas
Multiple Myeloma
Bone Neoplasm
Treatment
CC-122
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Understand and voluntarily sign an informed consent document prior to any studyrelated assessments/procedures are conducted.
- Men and women, 18 years or older, with histologically or cytologically-confirmed,advanced solid tumors, Non-Hodgkin Lymphona (NHL), Multiple Myloma (MM), or advancedunresectable solid tumors limited to the tumor types below.
- Subjects who have progressed on (or not been able to tolerate) standardanticancer therapy or for whom no standard anticancer therapy exists. Must havedisease that is objectively measurable
- Measurable disease criteria:
- Subjects with Glioblastoma multiforme (GBM) do not have to have objectivelymeasurable disease at entry.
- For MM, Diffuse large B-cell lymphoma (DLBCL): Subjects must have diseasethat is objectively measurable, measurable levels of myeloma paraprotein inserum (> 0.5 g/dL) or urine (> 0.2 g excreted in a 24-hour collectionsample) for MM and measurable disease by Internatonal Working Group (IWG)for NHL (with at least one measurable lesion's longest diameter ≥ 2cm).
- For Primary Central Nervous System (CNS) Lymphoma (PCNSL): Subjects musthave disease that is objectively measurable by International Workshop toStandardize Baseline Evaluation and Response Criteria in Primary CNSLymphoma, Cerebrospinal Fluid (CSF) cytology (in case of leptomeningeal onlydisease), or vitreal aspiration cytology and/or retinal photographs (in caseof ocular lymphoma).
- Tumor specific inclusion criteria:
- DLBCL-2 cohort:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
- Histologically proven diffuse large B-cell non-Hodgkin's lymphoma
- Must have progressed following or have been unable to tolerate at least oneprior anthracycline or alkylating agent containing regimen (with or withoutanti-CD20).
- Platelets ≥ 60 x 109/L.
- For PCNSL cohort:
- ECOG Performance Status of ≤ 2
- Recurrent/refractory CNS non-Hodgkin's lymphoma involving CNS (Brain,Cerebrospinal fluid (CSF) or intraocular compartments)
- Stable dose of glucocorticoids pre-therapy. If patients are receivingglucocorticoids, the dose should not increase during the 96 hours prior toinitiation of therapy.
- ECOG Performance Status of ≤ 2.
- For glioblastoma multiforme (GBM-2) cohort:
- ECOG Performance Status of ≤ 2
- Primary GBM or gliosarcoma
- ECOG Performance Status of ≤ 2.
- Has received prior treatment including radiation and chemotherapy, withradiation completed > 12 weeks prior to Day 1 (or ≥ 4 weeks if therecurrence is outside of the prior radiation field).
- Progression of disease after last therapy demonstrated by RANO criteria
- No prior therapy with Avastin
- No prior or scheduled Gliadel® wafer implant unless area of assessment andplanned resection is outside the region previously implanted.
- No prior interstitial brachytherapy or stereotactic radiosurgery unless areaof assessment and planned resection is outside the region previouslytreated.
- No enzyme-inducing anti-epileptic drugs (EIAED) such as carbamazepine,phenytoin, phenobarbital, or primidone within 14 days before Day 1.
- Able to undergo repeated magnetic resonance imaging (magnetic resonanceimaging (MRI), computed tomography (CT) scans).
- Availability of adequate Formalin-fixed, paraffin embedded (FFPE) archivaltumor material.
- Platelets (plt) ≥ 100 x 109/L.
- For Multiple Myeloma cohort
- ECOG Performance Status of ≤ 1.
- Have a documented diagnosis of multiple myeloma and have relapsed andrefractory disease.
- Measurable levels of myeloma paraprotein (M-protein) in serum (> 0.5 g/dL) orurine (> 0.2 g excreted in a 24-hour collection sample).
- Patients must have received at least 2 prior therapies.
- Patients must have relapsed after having achieved at least stable diseasefor at least one cycle of treatment to at least one prior regimen and thendeveloped PD.
- Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with thelast anti-myeloma drug regimen used just prior to study entry (refractorydisease).
- Patients must have also undergone prior treatment with at least 2 cycles oflenalidomide and at least 2 cycles of a proteosome inhibitor (either inseparate regimens or within the same regimen).
- Must be Pomalidomide naïve.
- Last dose of therapeutic glucocorticosteroids given greater than 14 days prior tostart of study treatment.
- Platelets (plt) ≥ 75 x 109/L in subjects in whom < 50% of bone marrow mononuclearcells are plasma cells or ≥ 30 x 109/L in subjects in whom ≥ 50% of bone marrowmononuclear cells are plasma cells.
- At least 4 weeks from last dose of therapeutic glucocorticosteroids. Adrenalreplacement doses of glucocorticosteroids (up to the equivalent of 10 mg dailyprednisone) are allowed.
- Biopsies (DLBLC, MM): Diagnostic archival FFPE (either in tumor blocks orsectioned/mounted specimens) may be submitted in lieu of a pre-study research biopsyif it has been obtained no more than 1 year prior to enrollment and only afterdiscussion with the Celgene Medical Monitor
- If not specified above as tumor specific parameter subjects must have the followinglaboratory and hematologic parameters as follows:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without growth factor support for 7days (14 days if received pegfilgrastim).
- Hemoglobin (Hgb) ≥ 9 g/dL.
- Platelets (Plt) ≥100 x 109/L.
- Potassium within normal limits or correctable with supplements.
- AST/SGOT and ALT/SGPT ≤ 3 x upper limit of normal (ULN) or ≤ 5.0 x ULN if livertumor is present.
- Serum creatinine ≤ ULN (with value applied to Cockcroft-Gault equation) or 24hour clearance ≥ 50mL/min.
- Negative serum pregnancy test in females of childbearing potential
Exclusion
Exclusion Criteria:
- History of other carcinomas within the last 5 years except cured non-melanoma skincancer, curatively treated in-situ cervical cancer, or localized prostate cancer witha current Prostate-specific antigen (PSA) of <1.0 mg/dL on 2 evaluations at least 3months apart; the most recent evaluation must be no more than 4 weeks prior to Day 1of the study drug, or other malignancies that were completely resected or treatedStage 1/2 lesions currently in complete remission.
- Symptomatic central nervous system metastases (excluding Glioblastoma multiforrme (GBM) and Primary Central Nervous System Lymphoma (PCNSL). Subjects with brainmetastases that have been previously treated and are stable for 6 weeks are allowed.
- Known symptomatic acute or chronic pancreatitis.
- Any peripheral neuropathy ≥ National Cancer Institute Common Terminology Criteria forAdverse Events (NCI CTCAE) grade 2.
- Persistent diarrhea or malabsorption ≥ NCI CTCAE grade 2, despite medical management.
- Impaired cardiac function or clinically significant cardiac diseases, including any ofthe following:
- left ventricular ejection fraction (LVEF) < 45% as determined by multigatedacquisition (MUGA) scan or echocardiography (ECHO).
- Complete left bundle branch, or bifasicular block.
- Congenital long QT syndrome.
- Persistent or uncontrolled ventricular arrhythmias or atrial fibrillation.
- QTcF > 460 msec on screening Electrocardiography (ECG) (mean of triplicaterecordings).
- Unstable angina pectoris or myocardial infarction ≤ 3 months prior to startingCC-122.
- Troponin-T value > 0.4 ng/ml or BNP >300 pg/mL. ° Subjects with baseline troponin-T >Upper Limit of Normal (ULN) or B-typeNatriuretic Peptide (BNP) >100 pg/mL are eligible but must have cardiologistevaluation prior to enrollment in the trial for baseline assessment andoptimization of cardioprotective therapy.
- Other clinically significant heart disease such as congestive heart failurerequiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mmHg).
- Other concurrent severe and/or uncontrolled concomitant medical conditions (eg, activeor uncontrolled infection or renal disease) that could cause unacceptable safety risksor compromise compliance with the protocol.
- Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half livesor 4 weeks, whichever is shorter, prior to starting study drug or who have notrecovered from side effects of such therapy.
- Major surgery ≤ 2 weeks prior to starting study drug or still recovering from postoperative side effects.
- Women who are pregnant or breast feeding. Adults of reproductive potential notemploying two forms of birth control as per Pregnancy Prevention Risk Management Plan.
- Known Human immunodeficiency virus (HIV) infection.
- Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity insubjects with Hepatocellular carcinoma (HCC).
- Status post solid organ transplant.
- Less than 100 days for subjects receiving autologous hematologic stem cell transplant (HSCT); or 6 months for subjects receiving allogenic HSCT or either transplant type,if otherwise not fully recovered from HSCT related toxicity.
- For MM-2 cohort only: Hypersensitivity (eg, Rash Grade 3 or 4) to thalidomide,lenalidomide, or dexamethasone (MM-2b).
- Any significant medical condition, laboratory abnormality, or psychiatric illness thatwould prevent the subject from participating in the study.
- Any condition including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if he/she were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
Study Design
Study Description
Connect with a study center
Local Institution - 401
Bruxelles, 1200
BelgiumSite Not Available
Local Institution - 400
Leuven, 3000
BelgiumSite Not Available
CHU Clemenceau
Clichy, Paris 92110
FranceSite Not Available
Institut Gustave Roussy
Villejuif, Paris 94805
FranceSite Not Available
Local Institution - 202
Caen Cedex, 14033
FranceSite Not Available
IPC
Marseille, 13009
FranceSite Not Available
Local Institution - 201
Marseille le Cedex, 13273
FranceSite Not Available
Local Institution - 205
Pierre Bénite, 69495
FranceSite Not Available
Local Institution - 203
Toulouse CEDEX 9, 31059
FranceSite Not Available
Institut Universitaire du Cancer IUCT - Oncopole
Toulouse Cedex, 31059
FranceSite Not Available
Insitut Universitaire du Cancer IUCT - Oncopole
Toulouse Cedrex, 31059
FranceSite Not Available
Local Institution - 200
Villejuif Cedex, 94805
FranceSite Not Available
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fo
Napoli, Campania 80131
ItalySite Not Available
Local Institution - 303
Bologna, 40138
ItalySite Not Available
Local Institution - 305
Bologna, 40139
ItalySite Not Available
Local Institution - 300
Milan, 0
ItalySite Not Available
Local Institution - 302
Napoli, Campania, 80131
ItalySite Not Available
Local Institution - 304
Roma, 00144
ItalySite Not Available
Instituto clinic Humanitas
Rozzano, 20089
ItalySite Not Available
Local Institution - 301
Rozzano (MI), 20089
ItalySite Not Available
Local Institution - 103
Badalona (Barcelona), 8916
SpainSite Not Available
Local Institution - 101
Barcelona, 08035
SpainSite Not Available
Local Institution - 105
Barcelona, 08003
SpainSite Not Available
Local Institution - 102
Madrid, 28041
SpainSite Not Available
Local Institution - 104
Madrid, 28040
SpainSite Not Available
Local Institution - 106
Pamplona, 31008
SpainSite Not Available
Local Institution - 108
Salamanca, 37007
SpainSite Not Available
Local Institution - 107
Sevilla, 41013
SpainSite Not Available
Local Institution - 100
Valencia, 46010
SpainSite Not Available
University of Arizona Cancer Center
Tucson, Arizona 85724
United StatesSite Not Available
City of Hope Cancer Center
Duarte, California 91010-300
United StatesSite Not Available
UCLA Neuro-Oncology Program
Los Angeles, California 90095
United StatesSite Not Available
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California 94143-1270
United StatesSite Not Available
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United StatesSite Not Available
Henry Ford Medical Center - New Center One
Detroit, Michigan 48202-268
United StatesSite Not Available
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada 89169
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey University
New Brunswick, New Jersey 08901
United StatesSite Not Available
Local Institution - 020
New York, New York 10065
United StatesSite Not Available
Mount Sinai Hospital
New York, New York 10029
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
MUSC Rheumatology and Immunology Dept.
Charleston, South Carolina 29425
United StatesSite Not Available
Greenville Hospital System
Greenville, South Carolina 29605
United StatesSite Not Available
Sarah Cannon Research Institute Drug Development Unit
Nashville, Tennessee 37203
United StatesSite Not Available
Texas Oncology, PA - Dallas 75246
Dallas, Texas 75246
United StatesSite Not Available
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas 78229
United StatesSite Not Available
Swedish Medical Center Cancer Institute Research
Seattle, Washington 98104
United StatesSite Not Available
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima, Washington 98902
United StatesSite Not Available
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