Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

NCT02548962 | Terminated Phase 1 Results DMC

• 2 other identifiers: PCYC-1138-CAPCI-32765
• Study Type: interventional
• Target: 11
• Locations: 6 countries
• Sites: 16

Brief Summary

Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Bruton's Tyrosine Kinase; PCI-32765; Pomalidomide; Dexamethasone; Relapsed Refractory Multiple Myeloma; Ibrutinib

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment

  The overall response rate, defined as the proportion of subjects achieving a best overall response of PR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy

  14 Months

Secondary Outcomes (2)

• Clinical Benefit Response (CBR)

  14 Months

• Duration of Response (DOR)

  14 Months

Study Arms (3)

Phase 1: Dose Finding

EXPERIMENTAL

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO

Drug: Ibrutinib; Drug: Pomalidomide; Drug: Dexamethasone

Phase 2: Treatment Arm A

EXPERIMENTAL

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO

Drug: Ibrutinib; Drug: Pomalidomide; Drug: Dexamethasone

Phase 2: Treatment Arm B

EXPERIMENTAL

Placebo PO+ Pomalidomide PO+ Dexamethasone PO

Drug: Pomalidomide; Drug: Dexamethasone; Drug: Placebo

Interventions

Ibrutinib DRUG

Phase 1: Dose Finding; Phase 2: Treatment Arm A

Pomalidomide DRUG

Phase 1: Dose Finding; Phase 2: Treatment Arm A; Phase 2: Treatment Arm B

Dexamethasone DRUG

Phase 1: Dose Finding; Phase 2: Treatment Arm A; Phase 2: Treatment Arm B

Placebo DRUG

Phase 2: Treatment Arm B

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen.
• Measurable disease defined by at least ONE of the following:
• Serum monoclonal protein (SPEP) ≥1 g/dL.
• Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine.
• Adequate hematologic, hepatic, and renal function
• ECOG performance status of ≤ 2

You may not qualify if:

• Subject must not have primary refractory disease
• Plasma cell leukemia, primary amyloidosis or POEMS syndrome
• Unable to swallow capsules or disease significantly affecting gastrointestinal function
• Requires treatment with strong CYP3A inhibitors
• Women who are pregnant or breast feeding.

Sponsors & Collaborators

• Pharmacyclics LLC.: lead
• Celgene Corporation: collaborator

Study Sites (16)

City of Hope

Duarte, California, 91010, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava, 708 52, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

'Alexandra' General Hospital of Athens

Athens, Attica, 11528, Greece

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ibrutinib; pomalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Bernhard Hauns, Medical Monitor
• Organization: Pharmacyclics Switzerland GmbH

bhauns@pcyc.com

+41 52 556 0800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 14, 2015
• Study Start: March 1, 2016
• Primary Completion: June 13, 2018
• Study Completion: June 13, 2018
• Last Updated: November 21, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-11

Locations

ES (4); GR (1); DE (1); US (5); AU (2); CZ (3)