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Multiple MyelomaPhase 2PANORAMA-5NCT02756663

Panobinostat in Combination With Carfilzomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma

A Phase 2 study testing panobinostat (capsules), carfilzomib (infusion) and dexamethasone (tablets) in people with Multiple Myeloma, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to investigate the anti-myeloma effect of panobinostat given at two different doses (10 mg and 20 mg oral) in combination with carfilzomib (20/56 mg/m2 i.v.) and low dose dexamethasone (20 mg oral) vs carfilzomib plus low-dose dexamethasone in patients with relapsed or relapsed and… 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 (capsules), carfilzomib (infusion) and dexamethasone (tablets)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2016to Feb 2021
Phase
Phase 2
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

  • Previous diagnosis of MM based on IMWG definitions (Rajkumar, 2014)
  • Prior treatment with 1 to 3 prior lines of therapy
  • Relapsed or relapsed and refractory MM
  • Measureable disease at screening based on central laboratory assessment
  • ECOG Performance status ≤ 2
  • Acceptable lab values prior to starting study treatment

Who cannot join

  • Primary refractory myeloma
  • Prior treatment with DAC inhibitors including panobinostat
  • Prior treatment with carfilzomib
  • Allogeneic stem cell transplant recipient with graft versus host disease (either active or requiring immunosuppression)
  • Any concomitant anti-cancer therapy besides the study treatment (bisphosphonates are permitted only if commenced prior to the start of screening period)
  • Intolerance to dexamethasone or contraindication to carfilzomib or dexamethasone
  • Unresolved diarrhea ≥ CTCAE grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)
  • Other protocol-defined inclusion/exclusion criteria may apply.

About this study

Official title: A Randomized, Triple-arm, Controlled, Open-label, Multicenter Phase II Study Assessing Two Different Doses of Panobinostat in Combination With Carfilzomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma

The purpose of this study is to investigate the anti-myeloma effect of panobinostat given at two different doses (10 mg and 20 mg oral) in combination with carfilzomib (20/56 mg/m2 i.v.) and low dose dexamethasone (20 mg oral) vs carfilzomib plus low-dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma. Safety and efficacy will be evaluated. Treatment will be administered in 4-week cycles until patients discontinue due to disease progression or unacceptable toxicity or for other reasons.

Patients who discontinue the study treatment for reasons other than documented disease progression will be followed for disease assessments every 8 weeks until progression. All patients will be followed for survival until 3 years have passed from their entry into the study, or they have discontinued the follow up earlier.

Being tested
panobinostat (capsules), carfilzomib (infusion), dexamethasone (tablets)
Keywords
multiple myeloma, MM, relapsed, relapsed and refractory, panobinostat, LBH589, histone deacetylase inhibitor, carfilzomib, proteasome inhibitor
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • panobinostat (capsules)Drug

    Also called PAN, LBH589

    Panobinostat capsules, oral: 10mg, 15mg, 20mg dosing 3x a week, 1 week on / 1 week off, in a 4 week cycle (28 days). Treatment arm A: only capsules of 10mg will be used Treatment arm B: capsules of 10mg and 15mg are foreseen for dose reduction only.

  • carfilzomib (infusion)Drug

    Also called CFZ

    Carfilzomib infusion; 20 mg/m2 i.v. on C1D1 and C1D2; 56 mg/m2 i.v. on subsequent dosing days (2x a week; 3 weeks on/1 weeks off ); 4 week cycle (28 days)

  • dexamethasone (tablets)Drug

    Also called Dex

    Dexamethasone tablets p.o. 20 mg on days of carfilzomib infusion (2x week) and on D22 and D23 of each 4 week cycle (28 days)

Study groups in NCT02756663
Study groupRoleWhat they receive
Arm A: PAN (10mg) + CFZ + DexExperimentalPanobinostat (PAN) 10mg orally, combined with carfilzomib (CFZ) 20/56 mg/m2 i.v. and dexamethasone (Dex) 20mg orally, in 4 week cycle
Receives: Drug: panobinostat (capsules); Drug: carfilzomib (infusion); Drug: dexamethasone (tablets)
Arm B: PAN (20mg) + CFZ + DexExperimentalPanobinostat (PAN) 20mg orally, combined with carfilzomib (CFZ) 20/56 mg/m2 i.v. and dexamethasone (Dex) 20mg orally, in 4 week cycle
Receives: Drug: panobinostat (capsules); Drug: carfilzomib (infusion); Drug: dexamethasone (tablets)
Arm C: CFZ + DexActive comparatorCarfilzomib (CFZ) 20/56 mg/m2 i.v. and dexamethasone (Dex) 20mg orally, in 4 week cycle
Receives: Drug: carfilzomib (infusion); Drug: dexamethasone (tablets)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR) using investigator's response assessment

    The primary endpoint if Overall Response Rate (ORR) using investigator response assessment according to IMWG criteria. The analysis of ORR will be performed after all randomized patients have completed 6 months of study treatment or discontinued treatment earlier.

    Measured: All patients treated for 6 cycles (cycle=28 days)

Secondary outcomes (11)

  1. Very Good Partial Response (VGPR) or better as best response using investigator response assessment based on International Myeloma Working Group (IMWG) criteria

    Investigators' response assessment assessed on IMWG criteria will be used. The VGPR or better rate is defined as the proportion of patients with a confirmed VGPR or better response as their best overall response.

    Measured: All patients treated for 6 cycles (cycle=28 days)

  2. Progression-free survival (PFS) using investigator's response assessment based on IMWG criteria

    PFS is defined as the time from date of randomization to date of first documented disease progression or death (regardless of cause of death).

    Measured: All patients treated for 6 cycles (cycle=28 days)

  3. Overall survival (OS)

    OS is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.

    Measured: All patients treated for 6 cycles (cycle=28 days)

  4. Time to response (TTR) using investigator's response assessment based on IMWG criteria

    TTR is the time between date of randomization to the date of first onset of partial response (PR) or better response.

    Measured: All patients treated for 6 cycles (cycle=28 days)

  5. Duration of Response (DOR) using investigator's response assessment based on IMWG criteria

    DOR is defined as the duration from the first documented onset of PR or better response the date of first documented disease progression or death due to multiple myeloma. DOR will use only the patients with PR or better as their best response.

    Measured: All patients treated for 6 cycles (cycle = 28 days)

  6. Time to progression (TTP) using investigator's response assessment based on IMWG criteria

    TTP is defined as the time from the date of randomization to the ate of the first documented disease progression or death due to multiple myeloma.

    Measured: All patients treated for 6 cycles (cycle = 28 days)

  7. Time to reach Cmax for panobinostat (PAN) and carfilzomib (CFZ)

    The maximum (peak) observed plasma concentration after single and multiple dose administration (ng/mL) of PAN and CFZ.

    Measured: All patients treated for 6 cycles (cycle=28 days);

  8. Minimum observed plasma concentration (Cmin) for carfilzomib

    The minimum (trough) observed plasma concentration after single and multiple dose administration (ng/mL) of PAN and CFZ.

    Measured: All patients treated for 6 cycles (cycle=28 days)

  9. Concentration of panobinostat in blood plasma in 48 hrs after the dose.

    The area under the concentration-time curve (AUC) from time zero to 48 hours (ng*h/mL) after the dose of PAN

    Measured: All patients treated for 6 cycles (cycle = 28 days)

  10. Total carfilzomib exposure over time in blood plasma .

    The AUC from time zero to infinity (ng*h/mL) for CFZ.

    Measured: All patients treated for 6 cycles (cycle=28 days)

  11. Health related quality of life (HRQoL) change over time measured by EORTC questionnaire QLQ-C30 and QLQ-MY20 for disease symptoms

    HRQoL questionnaires are patient reported outcomes, which provide functional assessment of cancer therapy.

    Measured: All patients treated for 6 cycles (cycle=28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionFeb 2021 (estimated)
  4. Study completionFeb 2021 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02756663
Sponsor's protocol ID
CLBH589X2201
Acronym
PANORAMA-5
Status last verified
Nov 2016
First submitted
12 Apr 2016
Last updated
8 Nov 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing panobinostat (capsules), carfilzomib (infusion) and dexamethasone (tablets) in people with Multiple Myeloma, run by Novartis Pharmaceuticals.

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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Overall response rate (ORR) using investigator's response assessment (time frame: All patients treated for 6 cycles (cycle=28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02756663.

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 8 Nov 2016.

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