Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma

NCT02290431 | Completed Phase 2 Results

• 1 other identifier: CLBH589D1201
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.

Conditions

Relapse/Refractory Multiple Myeloma

Keywords

LBH589; panobinostat; bortezomib; dexamethasone; Phase II; bortezomib and dexamethasone; Japanese patients; relapsed/refractory multiple myeloma; Panobinostat (PAN)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate

  nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response.

  after 24 weeks (8 cycles; cycle = 21 days)

Secondary Outcomes (15)

• Progression Free Survival (PFS)

  duration of study up to approx. 4 years

• Overall Response Rate (ORR)

  24 weeks (8 cycles; cycle = 21 days)

• Overall Survival (OS)

  up to 30 days after end of study, approx. 4 years

• Minimal Response Rate (MRR) Per Investigator

  after 24 weeks (8 cycles; cycle = 21 days)

• Time to Response (TTR) Per Investigator

  duration of study up to approx. 4 years

Study Arms (1)

LBH589 + bortezomib + dexamethasone

EXPERIMENTAL

Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.

Drug: LBH589 (panobinostat); Drug: bortezomib; Drug: dexamethasone

Interventions

LBH589 (panobinostat) DRUG

Panobinostat (PAN) capsules were supplied at dose strengths of 10 mg and 15 mg. and dosed at 20mg during treatment phase 1 (21 days) and treatment phase 2 (42 days)

LBH589 + bortezomib + dexamethasone

bortezomib DRUG

Bortezomib (BTZ) s.c: 1.3 mg/m2 was administered during both treatment phase 1 (21 days) \& treatment phase 2 (42 days).

LBH589 + bortezomib + dexamethasone

dexamethasone DRUG

Dexamethasone (Dex): 20mg tablets taken during both treatment phase 1 (21 days \& treatment phase 2 (42 days)

LBH589 + bortezomib + dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient had a previous diagnosis of multiple myeloma
• Patient required retreatment for multiple myeloma
• Patient had measurable M component in serum or urine at study screening

You may not qualify if:

• Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy)
• Patient who had been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
• Patient received prior treatment with DAC inhibitors including panobinostat
• Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Nagoya, Aichi-ken, 467-8602, Japan

Location

Novartis Investigative Site

Kashiwa, Chiba, 277-8567, Japan

Location

Novartis Investigative Site

Matsuyama, Ehime, 790-8524, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Ōgaki, Gifu, 503-8502, Japan

Location

Novartis Investigative Site

Maebashi, Gunma, 371 8511, Japan

Location

Novartis Investigative Site

Shibukawa, Gunma, 377-0280, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0047, Japan

Location

Novartis Investigative Site

Higashiibaraki-gun, Ibaraki, 311-3193, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 602-8566, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 983 8520, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 701-1192, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565 0871, Japan

Location

Novartis Investigative Site

Koto Ku, Tokyo, 135 8550, Japan

Location

Novartis Investigative Site

Shibuya City, Tokyo, 150-8935, Japan

Location

Novartis Investigative Site

Shinjuku Ku, Tokyo, 162 8655, Japan

Location

Novartis Investigative Site

Tachikawa, Tokyo, 190-0014, Japan

Location

Novartis Investigative Site

Aomori, 030 8553, Japan

Location

Novartis Investigative Site

Niigata, 951-8566, Japan

Location

Novartis Investigative Site

Tokushima, 770-8503, Japan

Location

Related Publications (1)

• Suzuki K, Sunami K, Matsumoto M, Maki A, Shimada F, Suzuki K, Shimizu K. Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Panobinostat in Combination with Bortezomib and Dexamethasone in Japanese Patients with Relapsed or Relapsed-and-Refractory Multiple Myeloma. Acta Haematol. 2021;144(3):264-274. doi: 10.1159/000508529. Epub 2020 Dec 4.

  PMID: 33279887 DERIVED

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

Panobinostat; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: November 14, 2014
• Study Start: December 16, 2014
• Primary Completion: December 29, 2017
• Study Completion: December 25, 2018
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (20)