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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02548962




Registration number
NCT02548962
Ethics application status
Date submitted
3/09/2015
Date registered
14/09/2015
Date last updated
21/11/2019

Titles & IDs
Public title
Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Scientific title
A Randomized Multicenter Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
PCI-32765
Secondary ID [2] 0 0
PCYC-1138-CA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ibrutinib
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Placebo

Experimental: Phase 1: Dose Finding - Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO

Experimental: Phase 2: Treatment Arm A - Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO

Experimental: Phase 2: Treatment Arm B - Placebo PO+ Pomalidomide PO+ Dexamethasone PO


Treatment: Drugs: Ibrutinib


Treatment: Drugs: Pomalidomide


Treatment: Drugs: Dexamethasone


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
14 Months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
14 Months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
14 Months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
South Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Czechia
State/province [6] 0 0
Brno
Country [7] 0 0
Czechia
State/province [7] 0 0
Ostrava
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha
Country [9] 0 0
Germany
State/province [9] 0 0
Dresden
Country [10] 0 0
Greece
State/province [10] 0 0
Attiki
Country [11] 0 0
Spain
State/province [11] 0 0
Navarra
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
Spain
State/province [13] 0 0
Salamanca
Country [14] 0 0
Spain
State/province [14] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pharmacyclics LLC.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Celgene Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02548962
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02548962