NCT01962792 · REGISTRY CONDITION SEARCH

Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2021-12-21

A MULTICENTER PHASE 1/2B STUDY OF THE BRUTON'S TYROSINE KINASE INHIBITOR, IBRUTINIB (PCI-32765), IN COMBINATION WITH CARFILZOMIB (KYPROLIS™) IN SUBJECTS WITH RELAPSED OR RELAPSED AND REFRACTORY MULTIPLE MYELOMA

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression Free Survival (PFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Measurable disease of MM as defined by at least ONE of the following: 1. Serum monoclonal protein (SPEP) ≥1 g/dL 2. Urine M-protein ≥200 mg/24 hrs 3. Serum free light chain (SFLC): involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal kappa to lambda serum free light chain ratio * Relapsed or relapsed and refractory MM after receiving at least 2 previous therapies, including an immunomodulator and bortezomib and had either no response or documented disease progression (according to IMWG criteria) to the most recent treatment regimen * Adequate hematologic, hepatic, and renal function * ECOG performance status of 0-2 Inclusion Criteria for Phase 2 Sub-study Cohort: * Must meet all inclusion criteria defined in main study and in addition the following criteria must be met: * Subject must have received a regimen containing carfilzomib in combination with dexamethasone as their most recent line of therapy and have: 1. Achieved less than a partial response (\<PR) following at least 4 cycles and are without evidence of progression disease (PD). OR 2. Disease progression following an initial confirmed response of MR or better to the combination (according to IMWG response criteria). 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 anti-coagulation with warfarin or a vitamin K antagonist * Requires treatment with strong CYP3A inhibitors Exclusion Criteria for Phase 2 Sub-study Cohort: * Must not meet any exclusion criteria defined in main study except for exclusion criteria "Subject must not have primary refractory disease" which is related to prior carfilzomib
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Ibrutinib PO 560mg + Carfilzomib IV 20/27mg/m2 + Dexamethasone PO 20mg
intervention Names
Drug: Ibrutinib
Drug: Carfilzomib
Drug: Dexamethasone
label
Phase 1 - Dose Finding
type
EXPERIMENTAL
description
Ibrutinib PO 560mg + Carfilzomib IV 20/36mg/m2 + Dexamethasone PO 20mg
intervention Names
Drug: Ibrutinib
Drug: Carfilzomib
Drug: Dexamethasone
label
Phase 2b - Main Study
type
EXPERIMENTAL
description
Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg
intervention Names
Drug: Ibrutinib
Drug: Carfilzomib
Drug: Dexamethasone
label
Phase 2b - Sub-study
type
EXPERIMENTAL

interventions

arm Group Labels
Phase 1 - Dose Finding
Phase 2b - Main Study
Phase 2b - Sub-study
name
Ibrutinib
type
DRUG
arm Group Labels
Phase 1 - Dose Finding
Phase 2b - Main Study
Phase 2b - Sub-study
name
Carfilzomib
type
DRUG
arm Group Labels
Phase 1 - Dose Finding
Phase 2b - Main Study
Phase 2b - Sub-study
name
Dexamethasone
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 84
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
-To evaluate the overall response (ORR) of ibrutinib in combination with carfilzomib and dexamethasone.
measure
Overall Response Rate (ORR)
time Frame
up to 4 years

secondary Outcomes

description
The time interval between the date of initial documentation of a response (PR or better) and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects who had not progressed/died. The censoring date was the last adequate tumor assessment date.
measure
Duration of Response (DOR)
time Frame
Up to 4 years
description
Time from date of first dose of study treatment to the date of death from any cause
measure
Overall Survival
time Frame
Up to 4 years
description
Time from date of first dose of study treatment to the date of first documented evidence of progressive disease, death or date of censoring for the subjects not progressed/died. The censoring date was the last adequate tumor assessment date.
measure
Progression Free Survival (PFS)
time Frame
Up to 4 years

Full study description

brief Summary: A MULTICENTER PHASE 1/2B STUDY OF THE BRUTON'S TYROSINE KINASE INHIBITOR, IBRUTINIB (PCI-32765), IN COMBINATION WITH CARFILZOMIB (KYPROLIS™) IN SUBJECTS WITH RELAPSED OR RELAPSED AND 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. PCI-32765 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 PCI-32765 in combination with carfilzomib (Kyprolis™) with and without dexamethasone in subjects with relapsed or relapsed and refractory multiple myeloma (MM).

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice