Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma

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Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma

Official Title

A Phase I/II Study of the Histone Deacetylase (HDAC) Inhibitor LBH589 (Panobinostat) in Combination With mTOR Inhibitor RAD001 (Everolimus) in Patients With Relapsed Multiple Myeloma or Lymphoma

Brief Summary

      This phase I/II trial studies the side effects and best dose of panobinostat and everolimus
      when given together and to see how well they work in treating patients with multiple myeloma,
      non-Hodgkin lymphoma, or Hodgkin lymphoma that has come back. Panobinostat and everolimus may
      stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximum tolerated doses (MTD) of LBH589 (panobinostat) and RAD001
      (everolimus) when used in combination in patients with myeloma or lymphoma. (Phase I) II. To
      evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with
      relapsed or refractory lymphoma. (Arm A, phase II) III. To evaluate the therapeutic activity
      of the combination of LBH589 with RAD001 in patients with relapsed or refractory multiple
      myeloma. (Arm B, phase II)

      SECONDARY OBJECTIVES:

      I. To describe the toxicities associated with the combination of LBH589 with RAD001. (Phase
      I) II. To further describe the toxicities associated with the combination of LBH589 with
      RAD001 in each arm independently. (Phase II) III. To evaluate overall survival,
      progression-free survival, and duration of response in each arm independently. (Phase II)

      TERTIARY OBJECTIVES:

      I. To evaluate the pharmacokinetic interaction of LBH589 and RAD001. II. To assess the
      correlation between clinical (toxicity and/or tumor response or activity) effects with the
      pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative
      laboratory) results.

      OUTLINE: This is a phase I, dose-escalation study of panobinostat and everolimus followed by
      a phase II study. (dose-escalation closed to accrual as of April 6, 2011)

      Patients receive panobinostat orally (PO) once daily (QD) or on days 1, 3, 5, 15, 17, and 19
      and everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 2 years.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)

Secondary Outcome

 Overall Survival Time (Phase II)

Condition

Adult Nasal Type Extranodal NK/T-cell Lymphoma

Intervention

panobinostat

Study Arms / Comparison Groups

 Treatment (panobinostat and everolimus)
Description:  Patients receive panobinostat PO QD or on days 1, 3, 5, 15, 17, and 19 and everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

124

Start Date

June 2009

Completion Date

July 16, 2019

Primary Completion Date

December 1, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Relapsed or refractory multiple myeloma requiring therapy, who have failed, unable to
             tolerate, or refused other available active therapies

          -  Biopsy-proven relapsed or refractory non-Hodgkin lymphoma or Hodgkin disease requiring
             treatment, who have failed, unable to tolerate, or refused other available active
             therapies; patients should not have other treatment options considered curative;
             (NOTE: for patients with lymphoma, a re-biopsy is necessary unless the patient has had
             a previous biopsy < 6 months prior to treatment on this protocol if there has been no
             intervening treatment; patients with biopsy-proven central nervous system [CNS]
             lymphoma at any time are not required to have a re-biopsy to be eligible for this
             study)

          -  Multiple myeloma:

               -  Serum monoclonal protein >= 1.0 g/dL

               -  >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

               -  Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum
                  immunoglobulin kappa to lambda free light chain ratio

               -  Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease) at time of
                  registration

          -  Lymphoma:

               -  Measurable disease by computed tomography (CT) or magnetic resonance imaging
                  (MRI) or the CT portion of the positron emission tomography (PET)/CT; must have
                  at least one lesion that has a single diameter of >= 2 cm or tumor cells in the
                  blood >= 5 x 10^9/L; skin lesions can be used if the area is >= 2 cm in at least
                  one diameter and photographed with a ruler

          -  The following disease types are eligible:

               -  Transformed lymphomas

               -  Diffuse large B cell lymphoma

               -  Mantle cell lymphoma

               -  Follicular lymphoma grade III

               -  Precursor B lymphoblastic leukemia/lymphoma

               -  Mediastinal (thymic) large B-cell lymphoma

               -  Burkitt lymphoma/leukemia

               -  Precursor T-lymphoblastic leukemia/lymphoma

               -  Primary cutaneous anaplastic large cell lymphoma

               -  Anaplastic large cell lymphoma - primary systemic type

               -  Small lymphocytic lymphoma/chronic lymphocytic leukemia

               -  Follicular lymphoma, grades 1, 2

               -  Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
                  (MALT) type

               -  Nodal marginal zone B-cell lymphoma

               -  Splenic marginal zone B-cell lymphoma

               -  Peripheral T cell lymphoma, unspecified.

               -  Anaplastic large cell lymphoma (T and null cell type)

               -  Lymphoplasmacytic lymphoma (Waldenstrom Macroglobulinemia)

               -  CNS lymphoma

               -  Post transplant lymphoproliferative disorders

               -  Mycosis fungoides/Sezary syndrome

               -  Hodgkin Disease

               -  Primary effusion lymphoma

               -  Blastic natural killer (NK)-cell lymphoma

               -  Adult T-cell leukemia/lymphoma

               -  Extranodal NK/T-cell lymphoma, nasal type

               -  Enteropathy-type T-cell lymphoma

               -  Hepatosplenic T-cell lymphoma

               -  Subcutaneous panniculitis-like T-cell lymphoma

               -  Angioimmunoblastic T-cell lymphoma

               -  Anaplastic large cell lymphoma - primary cutaneous type

          -  For lymphoplasmacytic lymphoma patients without measurable lymphadenopathy, measurable
             disease can be defined by both of the following criteria:

               -  Bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates,
                  sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow
                  biopsy and

               -  Quantitative immunoglobulin (Ig)M monoclonal protein > 1,000 mg/dL

          -  Absolute neutrophil count (ANC) >= 1000/uL

          -  Hemoglobin (Hgb) >= 9 g/dl

          -  Platelets (PLT) >= 75,000/uL

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x
             ULN the direct bilirubin must be normal

          -  Aspartate aminotransferase (AST) =< 3 x ULN

          -  Creatinine =< 2.5 x ULN

          -  Serum potassium, magnesium and phosphorus >= lower limit of normal (LLN) and =< 1.2 x
             ULN

          -  Ionized calcium >= LLN

          -  Thyroid-stimulating hormone (TSH) =< 1.5 x ULN; patients are permitted to receive
             thyroid hormone supplements to treat underlying hypothyroidism

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willingness to return to Mayo Clinic or National Cancer Institute, National Institutes
             of Health (NIH) - Medical Oncology Branch, Center for Cancer Research (CCR)

          -  Life expectancy >= 12 weeks

          -  Willing to provide blood samples for research studies as required by the protocol

          -  Negative pregnancy test done =< 7 days prior to registration, for women of
             childbearing potential only

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

        Exclusion Criteria:

          -  Candidate for known standard therapy for the patient's disease that is potentially
             curative

          -  Uncontrolled infection

          -  Therapy with myelosuppressive chemotherapy or biologic therapy < 3 weeks unless the
             patient has recovered from the nadir of the previous treatment to a level that meets
             the inclusion eligibility criteria of this protocol; NOTE: patients who have received
             prior RAD001 therapy will be allowed but must meet above requirements

          -  Receiving corticosteroids > 20 mg of prednisone per day (or equivalent); NOTE:
             patients may be receiving stable (not increased within the last month) chronic doses
             of corticosteroids with a maximum dose of 20 mg of prednisone per day if they are
             being given for disorders other than lymphoma (with the exception of CNS lymphoma,
             which steroids are permitted at the lowest possible dose necessary and should not be
             escalated during treatment) such as rheumatoid arthritis, polymyalgia rheumatica or
             adrenal insufficiency, or asthma

          -  Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy
             regardless of interval since last treatment

          -  Impaired cardiac function or clinically significant cardiac diseases, including any
             one of the following:

               -  Patients with congenital long QT syndrome

               -  History or presence of sustained ventricular tachyarrhythmia; (patients with a
                  history of atrial arrhythmia are eligible but should be discussed with the
                  Sponsor prior to enrollment)

               -  Any history of ventricular fibrillation or torsade de pointes

               -  Bradycardia defined as heart rate (HR) < 50 beats per minute (bpm;) patients with
                  pacemakers are eligible if HR >= 50 bpm

               -  Screening electrocardiogram (ECG) with a QTcFredericia (QTcF) > 450 msec

               -  Right bundle branch block + left anterior hemiblock (bifascicular block)

               -  Patients with myocardial infarction or unstable angina =< 6 months prior to
                  starting study drug

               -  Other clinically significant heart disease (e.g., congestive heart failure [CHF]
                  New York [NY] Heart Association class III or IV, uncontrolled hypertension,
                  history of labile hypertension, or history of poor compliance with an
                  antihypertensive regimen)

          -  Any of the following:

               -  Pregnant women or women of reproductive ability who are unwilling to use
                  effective contraception

               -  Nursing women

               -  Men who are unwilling to use a condom (even if they have undergone a prior
                  vasectomy) while having intercourse with any woman, while taking the drug and for
                  4 weeks after stopping treatment

          -  Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
             considered investigational (utilized for a non-Food and Drug Administration
             [FDA]-approved indication and in the context of a research investigation); NOTE:
             patients may undergo palliative concurrent radiation of myeloma lesions for pain
             control or impending fracture, provided the lesion(s) by themselves do not constitute
             progression

          -  Known positivity for human immunodeficiency virus (HIV) or hepatitis C with
             uncontrolled disease; baseline testing for HIV is not required; Note: a detailed
             assessment of Hepatitis B/C medical history and risk factors must be done at screening
             for all patients; hepatitis b virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C
             virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are
             required at screening for all patients with a positive medical history based on risk
             factors and/or confirmation of prior HBV infection

          -  Active other malignancy requiring treatment that would interfere with the assessments
             of response of the lymphoma or myeloma to protocol treatment

          -  Inability to swallow or impairment of gastrointestinal function or gastrointestinal
             disease that may significantly alter the absorption of the drugs (e.g., ulcerative
             disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small
             bowel resection) that would preclude use of oral medications

          -  Thrombotic or embolic events such as a cerebrovascular accident including transient
             ischemic attacks within the past 6 months

          -  Any severe and/or uncontrolled medical conditions or other conditions that, in the
             treating physician's opinion, could adversely impact their ability to participate in
             the study; NOTE: patients on chronic oxygen therapy, those with liver disease such as
             cirrhosis, chronic hepatitis or chronic persistent hepatitis, or uncontrolled
             infections will be excluded

          -  Known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus,
             temsirolimus)

          -  Receiving any medications or substances that are strong or moderate inhibitors of
             CYP3A4; receiving any medications or substances that are inducers of CYP3A4

          -  Using medications that have a relative risk of prolonging the QT interval or inducing
             torsade de pointes if treatment cannot be discontinued or switched to a different
             medication prior to starting study drug

          -  Active bleeding tendency; NOTE: patients on therapeutic anticoagulation should be
             monitored carefully to maintain therapeutic level of anticoagulation to avoid
             increased risk of bleeding due to concurrent drug induced thrombocytopenia; it is
             suggested that patients who require anticoagulation therapy while on therapy use low
             molecular weight heparin (LMWH)

          -  Major surgery =< 4 weeks prior to registration or have not recovered from side effects
             of such therapy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shaji Kumar, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00918333

Organization ID

MC0886

Secondary IDs

NCI-2009-00934

Responsible Party

Sponsor

Study Sponsor

Mayo Clinic

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Shaji Kumar, Principal Investigator, Mayo Clinic


Verification Date

March 2020