Expanded Treatment Prot of Panobinostat in Combo w/ Bortez and Dex in Pts w/ Relapsed and/or Refractory Multiple Myeloma

January 4, 2016 updated by: Novartis Pharmaceuticals

An Expanded Treatment Protocol of Panobinostat (LBH589) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma Who Have Had at Least One Prior Line of Therapy

This will be a multi-center, open label, expanded treatment protocol of panobinostat, bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma. Panobinostat will be administered at a starting dose of 20mg orally three times a week (every other day) for two weeks on and one week off, with dose adjustments permitted based on observed toxicity. Bortezomib will be administered either intravenously or sub-cutaneously, twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of treatment, patients who have achieved stable disease or better by modified EBMT 1998 criteria may continue combination therapy with bortezomib dosing changed to days 1 and 8 of a 21 day cycle for up to 48 weeks of therapy. At the end of the treatment period, (48 weeks) patients with stable disease or better may continue on therapy at the discretion of their investigator until September 2015 or until drug is commercially available, whichever comes first. Patients who have not achieved at least stable disease by 8 cycles must discontinue from study treatment. Dexamethasone will be administered on the day of and the day immediately following bortezomib treatment. Patients will not receive any study treatment during the third week of each cycle. Cycles will be defined as 21 days of treatment. Investigators may not add any other anti-myeloma agents (with the exception of bisphosphonates) while patients remain on study treatment. Patients will remain on study until disease progression, unacceptable toxicity, or end of the study

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer and Research Centers Ironwood Cancer
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group Dept of Highlands Oncology Grp
    • California
      • Anaheim, California, United States, 92807
        • Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C
      • Berkeley, California, United States, 94704
        • Alta Bates Cancer Center
      • Los Angeles, California, United States, 90017
        • Los Angeles Hematology/Oncology Medical Group
      • Stanford, California, United States, 94305
        • Stanford Cancer Center Stanford Cancer Institute (2)
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington U Medical Center Medical Faculty Associates
    • Florida
      • Boyton Beach, Florida, United States, 33426
        • University Cancer Institute Univ. Cancer Institute
      • Hollywod, Florida, United States, 33021
        • Memorial Cancer Institute Memorial Cancer Inst.
      • Miami Lakes, Florida, United States, 33014
        • Lakes Research SC
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine/Winship Cancer Institute Winship Cancer Institute (2)
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Stormont-Vail Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Hematology Oncology Clinic Hematology Oncology Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore Sinai Hospital, Baltimore
    • Michigan
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek Cancer Care Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-9941
        • University of Mississippi Medical Center Cancer Institute
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center Research Med. Center
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Oncology Hematology West, PC Nebraska Cancer Specialists
    • New Jersey
      • Little Silver, New Jersey, United States, 07739
        • Hematology Oncology of Central New Jersey
    • New York
      • New York, New York, United States, 10021
        • Morton Coleman, MD M. Coleman, MD (2)
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas GHS Cancer Institute
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Wellmont Medical Associates
    • Texas
      • Dallas, Texas, United States, 75251
        • Texas Oncology Texas Oncology - Arlington
      • Dallas, Texas, United States, 75251
        • Texas Oncology TX Oncology Baylor
    • Utah
      • Ogden, Utah, United States, 84403-3105
        • Northern Utah Cancer Associates SC
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates Virginia Oncology Assoc. (2)
    • Wisconsin
      • Appleton, Wisconsin, United States, 54915
        • Fox Valley Hematology and Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • This study is intended for patients with relapsed and/or refractory multiple myeloma, who have received at least one prior line of therapy. Patients must require retreatment as per IMWG definitions (Kyle et al 2003). Approximately 50-100 patients are expected to be enrolled into this trial.
  • Patient has a previous diagnosis of multiple myeloma, based on IMWG 2003 definitions all three of the following criteria had been met:
  • Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation on serum or on total 24 hour urine (or demonstration of M protein in cytoplasm of plasma cell for non secretory myeloma).
  • Bone marrow (clonal) plasma cells ≥ 10% or biopsy proven plasmacytoma
  • Related organ or tissue impairment (CRAB symptoms: anemia, hypercalcemia, lytic bone lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections)
  • Patients who have received allogeneic stem cell transplant and do not have active graft vs host disease requiring immunosuppressive therapy are eligible.
  • Patient with multiple myeloma (per IMWG 2003 definition) that is relapsed and/or refractory to at least one prior line of therapy and requires retreatment
  • Relapsed-and-refractory to a therapy, provided that the patient meets any of the following conditions:
  • Relapsed, defined by disease that recurred in a patient that responded under a prior therapy, by reaching a MR or better, and had not progressed under this therapy nor up to 60 days of last dose of this therapy. Patients who previously responded to treatment with BTZ are eligible.
  • Patient has relapsed to at least one prior line and patient was refractory to at least one prior line by either not reaching a MR, or progressed while under this therapy, or within 60 days of its last dose. Patients previously refractory to BTZ are also eligible.
  • Patients with primary refractory disease are eligible.
  • Patients who have previously received high dose therapy/autologous stem cell transplant are eligible
  • Patients who have received allogeneic stem cell transplant and do not have active graft vs host disease requiring immunosuppressive therapy are eligible

Exclusion Criteria:

  • Patient has shown intolerance to bortezomib, dexamethasone or panobinostat or has any contraindications to any of these therapies. following available prescribing information
  • Allogeneic stem cell transplant recipient presenting with graft versus host disease either active or requiring immunosuppression
  • Patient has grade ≥ 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination within 14 days of treatment
  • Patient taking any anti-cancer therapy concomitantly
  • Patient has second primary malignancy < 3 years of first dose of study treatment (except for treated basal or squamous cell carcinoma, or in situ cancer of the cervix)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLBH589DUS94X

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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