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Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01478581
Recruitment Status : Active, not recruiting
First Posted : November 23, 2011
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: PCI-32765
Drug: Dexamethasone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Simon 2-stage design . Stage 1 -13 subjects enrolled in cohort 1. For cohort 2,3, and 4, up to 18 subjects were enrolled in Stage 1. Cohort 4 was selected for expansion for enrollment of 43 subjects in Stage 2.

Reporting Groups
  Description
PCI-32765 420 mg Per Day

PCI-32765 420 mg per day

PCI-32765

PCI-32765 560 mg Per Day, 40 mg Dexamethasone

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

PCI-32765

Dexamethasone

PCI-32765 840 mg Per Day

PCI-32765 840 mg per day

PCI-32765

PCI-32765 840 mg Per Day, 40 mg Dexamethasone

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

PCI-32765

Dexamethasone


Participant Flow:   Overall Study
    PCI-32765 420 mg Per Day   PCI-32765 560 mg Per Day, 40 mg Dexamethasone   PCI-32765 840 mg Per Day   PCI-32765 840 mg Per Day, 40 mg Dexamethasone
STARTED   13   18   18   43 [1] 
COMPLETED   13   18   18   43 
NOT COMPLETED   0   0   0   0 
[1] Simon 2-stage design - cohort 4 expansion per stage 1 data (≥3 Clinical Benefit Responders observed



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cohort 1

PCI-32765 420 mg per day

PCI-32765

Cohort 2

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

PCI-32765

Dexamethasone

Cohort 3

PCI-32765 840 mg per day

PCI-32765

Cohort 4

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

PCI-32765

Dexamethasone

Total Total of all reporting groups

Baseline Measures
   Cohort 1   Cohort 2   Cohort 3   Cohort 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   18   18   43   92 
Age 
[Units: Years]
Median (Standard Deviation)
 62.0  (7.57)   65.5  (8.44)   65.5  (7.52)   65.0  (7.40)   65.0  (7.63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      5  38.5%      9  50.0%      5  27.8%      17  39.5%      36  39.1% 
Male      8  61.5%      9  50.0%      13  72.2%      26  60.5%      56  60.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      0   0.0%      0   0.0%      1   5.6%      6  14.0%      7   7.6% 
Not Hispanic or Latino      13 100.0%      18 100.0%      17  94.4%      34  79.1%      82  89.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      3   7.0%      3   3.3% 
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
         
Other Race           
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      1   5.6%      0   0.0%      1   1.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  15.4%      6  33.3%      4  22.2%      6  14.0%      18  19.6% 
White      10  76.9%      12  66.7%      12  66.7%      33  76.7%      67  72.8% 
More than one race      0   0.0%      0   0.0%      1   5.6%      0   0.0%      1   1.1% 
Unknown or Not Reported      1   7.7%      0   0.0%      0   0.0%      4   9.3%      5   5.4% 
[1] We have 5 patients with Race reported as "Other". For these 5 patients we reported the race data under "Unknown or Not Reported" as no "Other" category available in this database.
Region of Enrollment 
[Units: Participants]
         
United States   13   18   18   43   92 


  Outcome Measures

1.  Primary:   The Clinical Benefit Response (CBR)   [ Time Frame: From the date of first study treatment until disease progression per IMWG, up to 60 months ]

2.  Secondary:   To Evaluate the Efficacy of PCI-32765 by Assessing ORR   [ Time Frame: From the date of first study treatment until disease progression per IMWG, up to 60 months ]

3.  Secondary:   Pharmacokinetics (PK). (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Procedure was performed up to 60 weeks. ]

4.  Secondary:   Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Time to Maximum Observed Plasma Concentration (Tmax).   [ Time Frame: Procedure was performed up to 60 weeks. ]

5.  Secondary:   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).   [ Time Frame: Procedure was performed up to 60 weeks. ]

6.  Secondary:   Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Terminal Elimination Half-life (t1/2,Term).   [ Time Frame: Procedure was performed up to 60 weeks. ]

7.  Secondary:   Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Accumulation Ratio for AUC0-24h (Acc. Ratio AUC0-24h)   [ Time Frame: Procedure was performed up to 60 weeks. ]

8.  Secondary:   Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for Cmax (M/P Cmax)   [ Time Frame: Procedure was performed up to 60 weeks. ]

9.  Secondary:   Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for AUC0-24h (M/P AUC0-24h)   [ Time Frame: Procedure was performed up to 60 weeks. ]

10.  Secondary:   Duration of Clinical Benefit Response (DCB)   [ Time Frame: From the date of first study treatment until disease progression per IMWG, up to 60 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Zeena Salman, Associate Director, Clinical Science
Organization: Pharmacyclics LLC
phone: +1 (408) 215-3009
e-mail: ZSalman@pcyc.com



Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT01478581     History of Changes
Other Study ID Numbers: PCYC-1111-CA
PCI-32765 ( Other Identifier: Sponsor )
First Submitted: November 18, 2011
First Posted: November 23, 2011
Results First Submitted: January 22, 2018
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018