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Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma (PANORAMA_3)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02654990
First received: December 16, 2015
Last updated: June 19, 2017
Last verified: June 2017
  Purpose

The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression.

Patients will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons.

Patients who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks.

All patients will be followed for survival until the last patient entering long-term follow-up has completed a 3 year survival follow-up or discontinued earlier.


Condition Intervention Phase
Multiple Myeloma Drug: panobinostat capsules Drug: bortezomib injection Drug: dexamethasone tablets Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label Phase 2 Study Evaluating the Safety and Efficacy of Three Different Regimens of Oral Panobinostat in Combination With Subcutaneous Bortezomib and Oral Dexamethasone in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma Who Have Been Previously Exposed to Immunomodulatory Agents

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Overall response rate (ORR) up to 8 cycles [ Time Frame: up to 8 cycles per patient, approximately 30 months ]
    assessed according to IMWG guidelines


Secondary Outcome Measures:
  • ORR throughout study [ Time Frame: approximately 70 months ]
  • individual immunophenotypic complete response (CR) rate [ Time Frame: approximately 30 and 70 months ]
  • Progression-free survival [ Time Frame: approximately 30 and 70 months ]
  • Maximum plasma concentration (Cmax) for panobinostat (PAN) and bortezomib (BTZ) [ Time Frame: approximately 30 months ]
  • Time to progression [ Time Frame: approximately 30 and 70 months ]
  • Time to response [ Time Frame: approximately 30 and 70 months ]
  • Duration of response (DOR) [ Time Frame: approximately 30 and 70 months ]
  • European Organization of Research and Treatment of Cancer Quality of Life core 30-item questionnaire scores over time compared [ Time Frame: approximately 30 and 70 months ]
    EORTC QLQ-C30 on-treatment and in post treatment follow-up

  • individual stringent CR rate [ Time Frame: approximately 30 and 70 months ]
  • individual CR rate [ Time Frame: approximately 30 and 70 months ]
  • overall survival [ Time Frame: approximately 30 and 70 months ]
  • individual Very Good Partial Response rate [ Time Frame: approximately 30 and 70 months ]
  • Functional Assessment of Cancer Therapy / Gynecologic Oncology Group - Neurotoxicity scale scores over time [ Time Frame: approximately 30 and 70 months ]
    FACT/GOG-Ntx on-treatment

  • Time to reach Cmax for PAN and BTZ [ Time Frame: approximately 30 months ]
  • Minimum observed plasma concentration (Cmin) for BTZ [ Time Frame: approximately 30 months ]
  • Observed plasma concentration 24 hours after single and multiple dose administration of PAN and BTZ [ Time Frame: 24 hours after every dose, approximately 30 months ]

Estimated Enrollment: 240
Actual Study Start Date: April 27, 2016
Estimated Study Completion Date: December 15, 2022
Estimated Primary Completion Date: April 17, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A - 20mg PAN TIW
20mg panobinostat three times a week, 2 weeks on/1week of in combination with s.c. bortezomib and p.o. dexamethasone
Drug: panobinostat capsules
20mg, 10mg or 15mg (for dose reductions only)
Other Name: PAN, LBH589
Drug: bortezomib injection
1.3mg/m2 sub-cutaneous administration; Cycle 1-4: 2 weeks on/1 week off twice a week for patients <=75 years at time of screening; once a week for patient > 75 years Cycle 5+: once a week for all patients
Other Name: BTZ
Drug: dexamethasone tablets
pre and 24h after BTZ administration; patients <= 75 years at time of screening: 20mg/dose patients > 75 years: 10mg/dose
Other Name: Dex
Experimental: Arm B - 20mg PAN BIW
20mg panobinostat twice a week, 2 weeks on/1 week off in combination with s.c. bortezomib and p.o. dexamethasone
Drug: panobinostat capsules
20mg, 10mg or 15mg (for dose reductions only)
Other Name: PAN, LBH589
Drug: bortezomib injection
1.3mg/m2 sub-cutaneous administration; Cycle 1-4: 2 weeks on/1 week off twice a week for patients <=75 years at time of screening; once a week for patient > 75 years Cycle 5+: once a week for all patients
Other Name: BTZ
Drug: dexamethasone tablets
pre and 24h after BTZ administration; patients <= 75 years at time of screening: 20mg/dose patients > 75 years: 10mg/dose
Other Name: Dex
Experimental: Arm C - 10mg PAN TIW
10mg panobinostat three times a week 2 weeks on/1 week off in combination with s.c. bortezomib and p.o. dexamethasone
Drug: panobinostat capsules
20mg, 10mg or 15mg (for dose reductions only)
Other Name: PAN, LBH589
Drug: bortezomib injection
1.3mg/m2 sub-cutaneous administration; Cycle 1-4: 2 weeks on/1 week off twice a week for patients <=75 years at time of screening; once a week for patient > 75 years Cycle 5+: once a week for all patients
Other Name: BTZ
Drug: dexamethasone tablets
pre and 24h after BTZ administration; patients <= 75 years at time of screening: 20mg/dose patients > 75 years: 10mg/dose
Other Name: Dex

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • multiple myeloma as per IMWG 2014 definition
  • requiring treatment for relapsed or relapsed/refractory disease
  • measurable disease based on central protein assessment
  • 1 to 3 prior lines of therapy
  • prior IMiD exposure
  • acceptable lab values prior to starting study treatment

Exclusion Criteria:

  • primary refractory myeloma
  • refractory to bortezomib
  • concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates
  • prior treatment with DAC inhibitors
  • Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 month prior to screening)
  • Unresolved diarrhea ≥ CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02654990

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

  Show 72 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02654990     History of Changes
Other Study ID Numbers: CLBH589D2222
Study First Received: December 16, 2015
Last Updated: June 19, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
multiple myeloma
relapsed or relapsed/refractory
LBH589
panobinostat
bortezomib
dexamethasone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Panobinostat
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on June 22, 2017