ClinicalTrials.gov

History of Changes for Study: NCT02654990
Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma (PANORAMA_3)
Latest version (submitted March 15, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 January 11, 2016 None (earliest Version on record)
2 January 13, 2016 Outcome Measures and Study Status
3 April 25, 2016 Recruitment Status, Study Status and Contacts/Locations
4 May 26, 2016 Contacts/Locations and Study Status
5 July 25, 2016 Contacts/Locations and Study Status
6 September 23, 2016 Contacts/Locations and Study Status
7 October 20, 2016 Contacts/Locations and Study Status
8 November 22, 2016 Study Status and Contacts/Locations
9 January 3, 2017 Study Status and Contacts/Locations
10 February 8, 2017 Contacts/Locations and Study Status
11 February 23, 2017 Contacts/Locations and Study Status
12 May 15, 2017 Contacts/Locations, Study Status, Oversight and IPDSharing
13 May 30, 2017 Study Status and Contacts/Locations
14 June 19, 2017 Study Status
15 July 7, 2017 Study Status and Contacts/Locations
16 July 24, 2017 Contacts/Locations and Study Status
17 September 26, 2017 Study Status and Contacts/Locations
18 October 10, 2017 Study Status and Contacts/Locations
19 October 26, 2017 Contacts/Locations and Study Status
20 November 8, 2017 Contacts/Locations and Study Status
21 January 3, 2018 Study Status, Eligibility and Outcome Measures
22 March 2, 2018 Contacts/Locations and Study Status
23 March 19, 2018 Contacts/Locations and Study Status
24 October 29, 2018 Contacts/Locations and Study Status
25 November 16, 2018 Study Status and Contacts/Locations
26 December 4, 2018 Contacts/Locations and Study Status
27 December 14, 2018 Contacts/Locations and Study Status
28 January 3, 2019 Contacts/Locations and Study Status
29 January 13, 2019 Contacts/Locations and Study Status
30 January 18, 2019 Contacts/Locations and Study Status
31 February 6, 2019 Study Status and Contacts/Locations
32 February 7, 2019 Contacts/Locations and Study Status
33 February 12, 2019 Contacts/Locations and Study Status
34 February 14, 2019 Contacts/Locations and Study Status
35 February 18, 2019 Contacts/Locations and Study Status
36 February 21, 2019 Contacts/Locations and Study Status
37 February 27, 2019 Contacts/Locations and Study Status
38 March 4, 2019 Study Status and Contacts/Locations
39 April 3, 2019 Contacts/Locations and Study Status
40 May 23, 2019 Contacts/Locations and Study Status
41 June 9, 2019 Study Status and Contacts/Locations
42 June 13, 2019 Contacts/Locations and Study Status
43 June 30, 2019 Recruitment Status, Contacts/Locations, Study Status and Study Design
44 July 8, 2019 Study Status
45 August 9, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
46 August 29, 2019 Contacts/Locations and Study Status
47 December 5, 2019 Recruitment Status, Study Status, Contacts/Locations, Study Design
48 February 4, 2020 Contacts/Locations and Study Status
49 February 23, 2020 Study Status
50 February 27, 2020 Study Status
51 March 20, 2020 Contacts/Locations, Sponsor/Collaborators, Study Status, Study Identification and Eligibility
52 August 18, 2020 Study Status
53 March 15, 2021 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02654990
Submitted Date:  January 11, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: CLBH589D2222
Brief Title: Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma (PANORAMA_3)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2016
Overall Status: Not yet recruiting
Study Start: March 2016
Primary Completion: October 2021 [Anticipated]
Study Completion: October 2021 [Anticipated]
First Submitted: December 16, 2015
First Submitted that
Met QC Criteria:
January 11, 2016
First Posted: January 13, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 11, 2016
Last Update Posted: January 13, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

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.

Detailed Description:
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords: multiple myeloma
relapsed or relapsed/refractory
LBH589
panobinostat
bortezomib
dexamethasone
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 240 [Anticipated]
Open or close this module Arms and Interventions
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Dex
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall response rate (ORR) up to 8 cycles
[ Time Frame: up to 8 cycles per patient, approximately after 30 months ]

assessed according to IMWG guidelines
Secondary Outcome Measures:
1. ORR throughout study
[ Time Frame: approximately after 70 months ]

2. individual immunophenotypic complete response (CR) rate
[ Time Frame: approximately after 30 and 70 months ]

3. Progression-free survival
[ Time Frame: approximately after 30 and 70 months ]

4. Maximum plasma concentration (Cmax) for panobinostat (PAN) and bortezomib (BTZ)
[ Time Frame: approximately after 30 months ]

5. Time to progression
[ Time Frame: approximately after 30 and 70 months ]

6. Time to response
[ Time Frame: approximately after 30 and 70 months ]

7. Duration of response (DOR)
[ Time Frame: approximately after 30 and 70 months ]

8. European Organization of Research and Treatment of Cancer Quality of Life core 30-item questionnaire scores over time compared
[ Time Frame: approximately after 30 and 70 months ]

EORTC QLQ-C30 on-treatment and in post treatment follow-up
9. individual stringent CR rate
[ Time Frame: approximately after 30 and 70 months ]

10. individual CR rate
[ Time Frame: approximately after 30 and 70 months ]

11. overall survival
[ Time Frame: approximately after 30 and 70 months ]

12. individual Very Good Partial Response rate
[ Time Frame: approximately after 30 and 70 months ]

13. Functional Assessment of Cancer Therapy / Gynecologic Oncology Group - Neurotoxicity scale scores over time
[ Time Frame: approximately after 30 and 70 months ]

FACT/GOG-Ntx on-treatment
14. Time to reach Cmax for PAN and BTZ
[ Time Frame: approximately after 30 months ]

15. Minimum observed plasma concentration (Cmin) for BTZ
[ Time Frame: approximately after 30 months ]

16. Observed plasma concentration 24 hours after single and multiple dose administration of PAN and BTZ
[ Time Frame: 24 hours after every dose, approximately after 30 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.

Open or close this module Contacts/Locations
Central Contact Person: Novartis Pharmaceuticals
Telephone: 1-888-669-6682
Central Contact Backup: Novartis Pharmaceuticals
Study Officials: Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services