Panobinostat in Combination With Carfilzomib and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma (PANORAMA-5)

Novartis logo

Novartis

Status and phase

Withdrawn
Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: panobinostat (capsules)
Drug: dexamethasone (tablets)
Drug: carfilzomib (infusion)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02756663
CLBH589X2201

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Arm A: PAN (10mg) + CFZ + Dex
Experimental group
Description:
Panobinostat (PAN) 10mg orally, combined with carfilzomib (CFZ) 20/56 mg/m2 i.v. and dexamethasone (Dex) 20mg orally, in 4 week cycle
Treatment:
Drug: carfilzomib (infusion)
Drug: dexamethasone (tablets)
Drug: panobinostat (capsules)
Arm B: PAN (20mg) + CFZ + Dex
Experimental group
Description:
Panobinostat (PAN) 20mg orally, combined with carfilzomib (CFZ) 20/56 mg/m2 i.v. and dexamethasone (Dex) 20mg orally, in 4 week cycle
Treatment:
Drug: carfilzomib (infusion)
Drug: dexamethasone (tablets)
Drug: panobinostat (capsules)
Arm C: CFZ + Dex
Active Comparator group
Description:
Carfilzomib (CFZ) 20/56 mg/m2 i.v. and dexamethasone (Dex) 20mg orally, in 4 week cycle
Treatment:
Drug: carfilzomib (infusion)
Drug: dexamethasone (tablets)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems