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Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01050790
First Posted: January 15, 2010
Last Update Posted: November 29, 2016
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.
Collaborators:
National Cancer Institute (NCI)
Celgene Corporation
Information provided by (Responsible Party):
Virginia Commonwealth University
Results First Submitted: July 16, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: Azacitidine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Potential patients will be identified at the first BMT consult. They will then be preliminarily screened. If deemed eligible, they will be consented at the second BMT consult. After consent the subject will be officially screened for eligibility as described in the protocol. If eligible they will be enrolled.

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
Aza Len Lymphapheresis SCT ALI Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.

Participant Flow:   Overall Study
    Aza Len Lymphapheresis SCT ALI
STARTED   17 
COMPLETED   16 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics
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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.
Multiple Myeloma in either first or subsequent partial remission with measurable disease, eligible for autologous SCT.

Reporting Groups
  Description
Aza Len Lymphapheresis SCT ALI Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.

Baseline Measures
   Aza Len Lymphapheresis SCT ALI 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   4 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.59  (7.23) 
Gender 
[Units: Participants]
 
Female   7 
Male   10 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   17 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   10 
White   7 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Feasibility to Mobilize and Infuse Autologous Lymphocytes (ALI) After Immunomodulatory Therapy and After Stem Cell Transplant Engraftment   [ Time Frame: 6 months ]

2.  Secondary:   Complete Response Rate at 6 Months   [ Time Frame: 6 months ]

3.  Secondary:   Toxicity as Assessed by NCI CTCAE v3.0   [ Time Frame: 6 months ]

4.  Secondary:   Time to Progression Post Transplant   [ Time Frame: 28 months ]

5.  Secondary:   Progression-free and Overall Survival   [ Time Frame: 1 year to 2 years ]

6.  Secondary:   Pre- and Post-ALI Immune Response to Cancer Testis Antigens (CTA)   [ Time Frame: 6 months ]

7.  Secondary:   CTA Expression Before and After Azacitidine Therapy   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Amir A. Toor, MD, Associate Professor of Medicine
Organization: Virginia Commonwealth University/Massey Cancer Center
phone: 804-828-4360
e-mail: atoor@mcvh-vcu.edu



Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01050790     History of Changes
Other Study ID Numbers: CDR0000663409
P30CA016059 ( U.S. NIH Grant/Contract )
MCC-12430 ( Other Identifier: Massey Cancer Center )
First Submitted: January 14, 2010
First Posted: January 15, 2010
Results First Submitted: July 16, 2015
Results First Posted: October 5, 2015
Last Update Posted: November 29, 2016