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Multiple Myeloma

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Dexamethasone

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Panobinostat

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Enzyme Inhibitors

Panobinostat (PAN) 10mg orally, combined with carfilzomib (CFZ) 20/56 mg/m2 i.v. and dexamethasone (Dex) 20mg orally, in 4 week cycle

Panobinostat (PAN) 20mg orally, combined with carfilzomib (CFZ) 20/56 mg/m2 i.v. and dexamethasone (Dex) 20mg orally, in 4 week cycle

Carfilzomib (CFZ) 20/56 mg/m2 i.v. and dexamethasone (Dex) 20mg orally, in 4 week cycle

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.

panobinostat (capsules)

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)

carfilzomib (infusion)

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)

dexamethasone (tablets)

Novartis Pharmaceuticals

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.

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

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 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.

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.

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

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.

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

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.

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.

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Panobinostat in Combination With Carfilzomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma	NCT02756663	Multiple Myelom...	panobinostat (c... carfilzomib (in... dexamethasone (...	18 Years -	Novartis
Panobinostat in Combination With Carfilzomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma	NCT02756663	Multiple Myelom...	panobinostat (c... carfilzomib (in... dexamethasone (...	18 Years -	Novartis

Spots Global Cancer Trial Database for carfilzomib (infusion)