We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma

This study has been terminated.
(Did not pass the Stage 1 interim analysis.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01646762
First Posted: July 20, 2012
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
Results First Submitted: July 31, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Refractory Plasma Cell Myeloma
Interventions: Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Other: Laboratory Biomarker Analysis

  Participant Flow
  Hide 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
No text entered.

Reporting Groups
  Description
Treatment (Chemotherapy) Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV

Participant Flow:   Overall Study
    Treatment (Chemotherapy)
STARTED   13 
COMPLETED   13 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide 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
Treatment (Chemotherapy) Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV

Baseline Measures
   Treatment (Chemotherapy) 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Median (Full Range)
 70.0 
 (46.0 to 81.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  23.1% 
Male      10  76.9% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients Who Have a Confirmed Partial Response or Better   [ Time Frame: Up to 3 years ]

2.  Secondary:   Survival Time   [ Time Frame: Time from registration to death due to any cause, assessed up to 3 years ]

3.  Secondary:   Progression Free Survival at 3 Months   [ Time Frame: Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years ]

4.  Secondary:   Duration of Response of All Evaluable Patients Who Have Achieved a Partial Response or Better   [ Time Frame: Date at which the patient’s earliest best objective status is first noted to be at least a partial response or better to the earliest date progression is documented, assessed up to 3 years ]

5.  Secondary:   Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Up to 3 years ]

6.  Secondary:   Overall Response Rate   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Rafael Fonseca
Organization: Mayo Clinic
phone: 480-301-4280
e-mail: fonseca.rafael@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01646762     History of Changes
Other Study ID Numbers: MC1182
NCI-2012-00879 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
11-007291
MC1182 ( Other Identifier: Mayo Clinic in Arizona )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: June 19, 2012
First Posted: July 20, 2012
Results First Submitted: July 31, 2017
Results First Posted: September 1, 2017
Last Update Posted: October 16, 2017