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

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Pomalidomide
Dexamethasone
Placebo
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Bruton's Tyrosine Kinase, PCI-32765, Pomalidomide, Dexamethasone, Relapsed Refractory Multiple Myeloma, Ibrutinib

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    1. Serum monoclonal protein (SPEP) ≥1 g/dL.
    2. Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine.
  • Adequate hematologic, hepatic, and renal function
  • ECOG performance status of ≤ 2

Exclusion Criteria:

  • 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.

Sites / Locations

  • City of Hope
  • Dana-Farber Cancer Institute
  • Cleveland Clinic
  • Medical University of South Carolina
  • Virginia Commonwealth University
  • Concord Repatriation General Hospital
  • Princess Alexandra Hospital
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Ostrava
  • Vseobecna fakultni nemocnice v Praze
  • Universitätsklinikum Carl Gustav Carus
  • 'Alexandra' General Hospital of Athens
  • Clinica Universidad de Navarra
  • Hospital de La Santa Creu i Sant Pau
  • Hospital Universitario de Salamanca
  • Hospital Universitario Doctor Peset

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase 1: Dose Finding

Phase 2: Treatment Arm A

Phase 2: Treatment Arm B

Arm Description

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO

Placebo PO+ Pomalidomide PO+ Dexamethasone PO

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical Benefit Response (CBR)
The clinical benefit response, defined as the proportion of subjects achieving a best overall response of MR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy.
Duration of Response (DOR)
The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.

Full Information

First Posted
September 3, 2015
Last Updated
November 4, 2019
Sponsor
Pharmacyclics LLC.
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02548962
Brief Title
Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Official Title
A Randomized Multicenter Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
After completing Phase 1, the Sponsor elected not to move forward with Phase 2.
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
June 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. Ibrutinib is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Bruton's Tyrosine Kinase, PCI-32765, Pomalidomide, Dexamethasone, Relapsed Refractory Multiple Myeloma, Ibrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Dose Finding
Arm Type
Experimental
Arm Description
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Arm Title
Phase 2: Treatment Arm A
Arm Type
Experimental
Arm Description
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Arm Title
Phase 2: Treatment Arm B
Arm Type
Experimental
Arm Description
Placebo PO+ Pomalidomide PO+ Dexamethasone PO
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment
Description
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
Time Frame
14 Months
Secondary Outcome Measure Information:
Title
Clinical Benefit Response (CBR)
Description
The clinical benefit response, defined as the proportion of subjects achieving a best overall response of MR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy.
Time Frame
14 Months
Title
Duration of Response (DOR)
Description
The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.
Time Frame
14 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
'Alexandra' General Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
11528
Country
Greece
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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