Multiple MyelomaPhase 1NCT00532675
Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.
A Phase 1 study testing LBH589 and Lenalidomide in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 10 sites in 4 countries.
Trial summary
This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma 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?
- LBH589 and Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 22 Apr 2008to 8 Nov 2017
- Phase
- Phase 1
- 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
- Patients must have a diagnosis of active multiple myeloma
- Patients must have received at least one prior line of therapy and their disease has relapsed..
- Patients must be suitable for treatment with lenalidomide \& dexamethasone.
- Adults ≥ 18 years old
- ECOG Performance Status ≤ 2
- Life expectancy > 12 weeks
- Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.
- Able to sign informed consent and to comply with the protocol
Who cannot join
- Primary refractory MM
- Peripheral neuropathy ≥ CTCAE grade 2
- Impaired cardiac function or clinically significant cardiac diseases
- Impairment of GI function or GI disease that may significantly alter the absorption of LBH589
- Patients with diarrhea > CTCAE grade 1
- Patients using medications that have a relative risk of prolonging the QT interval
Show all 13Show fewer
- Concomitant use of CYP3A4 inhibitors
- Patients with a history of deep vein thrombosis or thromboembolism within < 6 months prior to starting study treatment
- Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using 2 reliable forms of birth control
- Male patients whose sexual partners are WOCBP and who are unable to use a latex condom during sexual contact (even if they have undergone a vasectomy)
- Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff.
- Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States3 sites
Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.
Atlanta, Georgia, 30322
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
UCSF Medical Center
San Francisco, California, 94143
France3 sites
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Nantes, 44035
Australia2 sites
Novartis Investigative Site
Prahran, Victoria, 3181
Novartis Investigative Site
South Brisbane, Queensland, 4101
Spain2 sites
Novartis Investigative Site
Salamanca, Castille and León, 37007
Novartis Investigative Site
Valencia, Valencia, 46026
About this study
Official title: A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma
This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma
- Conditions
- Multiple Myeloma
- Being tested
- LBH589, Lenalidomide
- Keywords
- Myeloma, Multiple Myeloma, Lenalidomide, Revlimid, Dexamethasone, LBH589, Combination
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBH589Drug
Also called Panobinostat, PAN
PAN 5 mg and PAN 20 mg capsules
LenalidomideCombination product
Lenalidomide 5mg or 25 mg
| Study group | Role | What they receive |
|---|---|---|
| PAN 5 mg | Experimental | Panobinostat 5 mg Receives: Drug: LBH589; Combination Product: Lenalidomide |
| PAN 10 mg | Experimental | Panobinostat 10 mg Receives: Drug: LBH589; Combination Product: Lenalidomide |
| PAN 20 mg | Experimental | Panobinostat 20 mg Receives: Drug: LBH589; Combination Product: Lenalidomide |
| PAN 25 mg | Experimental | Panobinostat 25 mg Receives: Drug: LBH589; Combination Product: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone
Measured: 24 weeks
Secondary outcomes (1)
Safety and tolerability assessed by monitoring of adverse events, serious adverse events and laboratory parameters To characterize the pharmacokinetic profile of the study treatment To characterize the pharmacodynamic profile of the study treatment
Measured: Da1 to Day 3 (week 1 of first cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study start22 Apr 2008
- Primary completion8 Nov 2017
- Study completion8 Nov 2017
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
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
- NCT00532675
- Sponsor's protocol ID
- CLBH589B2206
- Other IDs
- 2006-007030-35
- Status last verified
- Feb 2020
- First submitted
- 18 Sep 2007
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00532675
- Acronym / sponsor ID
- CLBH589B2206
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Multiple Myeloma, Lenalidomide, Revlimid, Dexamethasone, LBH589, Combination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2008 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 20 Sep 2007 (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 study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PAN 5 mg | Experimental | Drug: LBH589, Combination Product: LenalidomidePanobinostat 5 mg |
| PAN 10 mg | Experimental | Drug: LBH589, Combination Product: LenalidomidePanobinostat 10 mg |
| PAN 20 mg | Experimental | Drug: LBH589, Combination Product: LenalidomidePanobinostat 20 mg |
| PAN 25 mg | Experimental | Drug: LBH589, Combination Product: LenalidomidePanobinostat 25 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have a diagnosis of active multiple myeloma
- Patients must have received at least one prior line of therapy and their disease has relapsed..
- Patients must be suitable for treatment with lenalidomide \& dexamethasone.
- Adults ≥ 18 years old
- ECOG Performance Status ≤ 2
Key exclusion criteria (13 listed)
- Primary refractory MM
- Peripheral neuropathy ≥ CTCAE grade 2
- Impaired cardiac function or clinically significant cardiac diseases
- Impairment of GI function or GI disease that may significantly alter the absorption of LBH589
- Patients with diarrhea > CTCAE grade 1
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 |
|---|---|---|
| LBH589Also: Panobinostat, PANPAN 5 mg and PAN 20 mg capsules | Drug | PAN 10 mg, PAN 20 mg, PAN 25 mg, PAN 5 mg |
| LenalidomideLenalidomide 5mg or 25 mg | Combination product | PAN 10 mg, PAN 20 mg, PAN 25 mg, PAN 5 mg |
Primary outcome
To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone
Time frame: 24 weeks
1 secondary outcome
Safety and tolerability assessed by monitoring of adverse events, serious adverse events and laboratory parameters To characterize the pharmacokinetic profile of the study treatment To characterize the pharmacodynamic profile of the study treatment
Time frame: Da1 to Day 3 (week 1 of first cycle)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for CLBH589B2206 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LBH589 and Lenalidomide in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 10 sites in 4 countries.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, France, Australia, Spain. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
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 19 Dec 2020.