Phase 2
Completed N=124
Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma
Source: ClinicalTrials.gov NCT00918333 ↗Enrolled (actual)
124
Serious AEs
24.1%
Results posted
May 2018
Primary outcomePrimary: Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) |
— | — |
| PRIMARY Overall Response Rate (Phase II) |
39; 7; 20; 0 | — |
| SECONDARY Overall Survival Time (Phase II) |
17.1; 16.6; 35.4; 21.7 | — |
| SECONDARY Progression-free Survival (Phase II) |
3.7; 2.3; 4.2; 4.3 | — |
| SECONDARY Duration of Response (Phase II) |
9.1; NA; 12.9 | — |
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 = 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 ULN the direct bilirubin must be normal
- Aspartate aminotransferase (AST) = = lower limit of normal (LLN) and = = LLN
- Thyroid-stimulating hormone (TSH) = = 12 weeks
- Willing to provide blood samples for research studies as required by the protocol
- Negative pregnancy test done = 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
Data sourced from ClinicalTrials.gov (NCT00918333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.