Multiple MyelomaNCT02204553
Expanded Treatment Prot of Panobinostat in Combo w/ Bortez and Dex in Pts w/ Relapsed and/or Refractory Multiple Myeloma
A study testing Panobinostat in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 27 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Panobinostat
- How many people
- Not given
- Where
- 27 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C
Anaheim, California, 92807
Fox Valley Hematology and Oncology
Appleton, Wisconsin, 54915
Emory University School of Medicine/Winship Cancer Institute Winship Cancer Institute (2)
Atlanta, Georgia, 30322
Sinai Hospital of Baltimore Sinai Hospital, Baltimore
Baltimore, Maryland, 21215
Hematology Oncology Clinic Hematology Oncology Clinic
Baton Rouge, Louisiana, 70808
Bronson Battle Creek Cancer Care Center
Battle Creek, Michigan, 49017
Alta Bates Cancer Center
Berkeley, California, 94704
University Cancer Institute Univ. Cancer Institute
Boyton Beach, Florida, 33426
Wellmont Medical Associates
Bristol, Tennessee, 37620
Ironwood Cancer and Research Centers Ironwood Cancer
Chandler, Arizona, 85224
Texas Oncology Texas Oncology - Arlington
Dallas, Texas, 75251
Texas Oncology TX Oncology Baylor
Dallas, Texas, 75251
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, 72703
Cancer Centers of the Carolinas GHS Cancer Institute
Greenville, South Carolina, 29615
Memorial Cancer Institute Memorial Cancer Inst.
Hollywod, Florida, 33021
University of Mississippi Medical Center Cancer Institute
Jackson, Mississippi, 39216-9941
Research Medical Center Research Med. Center
Kansas City, Missouri, 64132
Hematology Oncology of Central New Jersey
Little Silver, New Jersey, 07739
Los Angeles Hematology/Oncology Medical Group
Los Angeles, California, 90017
Lakes Research SC
Miami Lakes, Florida, 33014
Morton Coleman, MD M. Coleman, MD (2)
New York, New York, 10021
Virginia Oncology Associates Virginia Oncology Assoc. (2)
Norfolk, Virginia, 23502
Northern Utah Cancer Associates SC
Ogden, Utah, 84403-3105
Oncology Hematology West, PC Nebraska Cancer Specialists
Omaha, Nebraska, 68124
Stanford Cancer Center Stanford Cancer Institute (2)
Stanford, California, 94305
Stormont-Vail Cancer Center
Topeka, Kansas, 66606
George Washington U Medical Center Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: 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
- Conditions
- Multiple Myeloma
- Being tested
- Panobinostat
- Keywords
- Multiple Myeloma, Panobinostat, LBH589, Expanded Access, EAP, ETP, Expanded Treatment, Bortezomib, HDAC, histone deacetylace inhibitor
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanobinostatDrug
Treating patients with relapsed and/or refractory Multiple Myeloma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204553
- Sponsor's protocol ID
- CLBH589DUS94X
- Status last verified
- Jan 2016
- First submitted
- 28 Jul 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02204553
- Acronym / sponsor ID
- CLBH589DUS94X
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Panobinostat, LBH589, Expanded Access, EAP, ETP, Expanded Treatment, Bortezomib, HDAC
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PanobinostatTreating patients with relapsed and/or refractory Multiple Myeloma | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panobinostat in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.