NCT01478581

Brief Summary

The primary objective of this study is to determine the efficacy of PCI-32765, both as a single agent and in combination with dexamethasone, in subjects with relapsed or relapsed and refractory Multiple Myeloma (MM)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_2 multiple-myeloma

Timeline
Completed

Started Mar 2012

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

June 26, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 10, 2020

Status Verified

October 1, 2019

Enrollment Period

6.4 years

First QC Date

November 18, 2011

Results QC Date

January 22, 2018

Last Update Submit

March 2, 2020

Conditions

Multiple Myeloma

Keywords

PCI-32765Multiple MyelomaRelapsed Refractory Multiple MyelomaBruton's Tyrosine Kinase

Outcome Measures

Primary Outcomes (1)

  • The Clinical Benefit Response (CBR)

    The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria

    From the date of first study treatment until disease progression per IMWG, up to 60 months

Secondary Outcomes (10)

  • To Evaluate the Efficacy of PCI-32765 by Assessing ORR

    From the date of first study treatment until disease progression per IMWG, up to 60 months

  • Pharmacokinetics (PK). (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Maximum Observed Plasma Concentration (Cmax)

    Procedure was performed up to 60 weeks.

  • Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Time to Maximum Observed Plasma Concentration (Tmax).

    Procedure was performed up to 60 weeks.

  • Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h).

    Procedure was performed up to 60 weeks.

  • Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Terminal Elimination Half-life (t1/2,Term).

    Procedure was performed up to 60 weeks.

  • +5 more secondary outcomes

Study Arms (4)

Cohort 1

EXPERIMENTAL

PCI-32765 420 mg per day

Drug: PCI-32765

Cohort 2

EXPERIMENTAL

PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week

Drug: PCI-32765Drug: Dexamethasone

Cohort 3

EXPERIMENTAL

PCI-32765 840 mg per day

Drug: PCI-32765

Cohort 4

EXPERIMENTAL

PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week

Drug: PCI-32765Drug: Dexamethasone

Interventions

PCI-32765DRUG
Also known as: Ibrutinib
Cohort 1Cohort 2Cohort 3Cohort 4
DexamethasoneDRUG
Cohort 2Cohort 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of symptomatic MM with measurable disease, defined here as having at least one of the following:
  • Serum monoclonal protein (M-protein) ≥0.5 g/dL as determined by serum protein electrophoresis (SPEP)
  • Urine M-protein ≥200 mg/24 hrs
  • Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal
  • Relapsed or relapsed and refractory MM after receiving at least 2 but no more than 5 previous lines of therapy, 1 of which must be an immunomodulator.
  • Refractory myeloma (to most recent treatment) is defined as disease that is nonresponsive while on treatment or progressive disease within 60 days after the completion of preceding treatment. Nonresponsive disease is defined as either failure to achieve minimal response or development of progressive disease while on therapy.
  • Men and women ≥18 years of age.
  • ECOG performance status of ≤ 1.

You may not qualify if:

  • Subject must not have primary refractory disease defined as disease that is nonresponsive in subjects who have never achieved a minor response (MR) or better with any therapy.
  • Polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome, osteosclerotic myeloma, or Crow-Fukase syndrome.
  • Plasma cell leukemia.
  • Primary amyloidosis.
  • ANC \<0.75 x 10\^9/L independent of growth factor support.
  • Platelets \<50 x 10\^9/L) independent of transfusion support.
  • AST or ALT ≥3.0 x upper limit of normal (ULN).
  • Total bilirubin \>2.5 x ULN, unless due to Gilbert's syndrome.
  • Creatinine \>2.5 mg/dL.
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function.
  • Requires anti-coagulation with warfarin or a vitamin K antagonist. Requires treatment with strong CYP3A4/5 inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

SITE-13

La Jolla, California, 92093, United States

Location

SITE-5

Baltimore, Maryland, 21287, United States

Location

SITE-4

Boston, Massachusetts, 02215, United States

Location

SITE-8

Ann Arbor, Michigan, 48109, United States

Location

SITE-2

St Louis, Missouri, 63110, United States

Location

SITE-6

Hackensack, New Jersey, 07601, United States

Location

SITE-10

New York, New York, 10029, United States

Location

SITE-3

New York, New York, 10065, United States

Location

SITE-1

Nashville, Tennessee, 37203, United States

Location

SITE-11

Dallas, Texas, 75390, United States

Location

SITE-9

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ibrutinibDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, 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 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 23, 2011

Study Start

March 1, 2012

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

March 10, 2020

Results First Posted

June 26, 2018

Record last verified: 2019-10

Locations

US(11)