We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission

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.
 
ClinicalTrials.gov Identifier: NCT01349569
Recruitment Status : Completed
First Posted : May 6, 2011
Results First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Lenalidomide
Biological: Allogeneic Myeloma Vaccine
Biological: Prevnar-13
Enrollment 19
Recruitment Details  
Pre-assignment Details Two participants were screen failures. One participant withdrew consent prior to starting the study.
Arm/Group Title Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Hide Arm/Group Description

Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.

Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

Period Title: Overall Study
Started 16
Completed 12
Not Completed 4
Reason Not Completed
Lack of Efficacy             4
Arm/Group Title Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Hide Arm/Group Description

Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.

Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
One participant withdrew consent prior to receiving the study intervention, leaving sixteen participants who received at least one day of intervention.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  37.5%
>=65 years
10
  62.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
68
(45 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  18.8%
White
11
  68.8%
More than one race
0
   0.0%
Unknown or Not Reported
1
   6.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
 100.0%
1.Primary Outcome
Title Response Conversion Rate
Hide Description Number of participants who converted from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis.
Arm/Group Title Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Hide Arm/Group Description:

Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.

Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
8
  53.3%
2.Secondary Outcome
Title Time to Response
Hide Description

Median time for conversion of response from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.

as measured by immunofixation converting from positive to negative.

Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis.
Arm/Group Title Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Hide Arm/Group Description:

Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.

Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: months
11.7
(2 to 47)
3.Secondary Outcome
Title Effect on Clonogenic Myeloma Precursors
Hide Description Measures of stem cell population and plasma cell population.
Time Frame Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure due to technical difficulties in the assay.
Arm/Group Title Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Hide Arm/Group Description:

Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.

Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Grade 3-4 Toxicity
Hide Description Number of participants who experienced grade 3-4 toxicity as per CTCAE 4.0.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Hide Arm/Group Description:

Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.

Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells
Hide Description Immunity is measured by the percentage of CD3+/CSFSE-low/IFN-gamma+ cells. A positive result for a given participant is defined as greater than two standard deviations above that participant's baseline. The data are presented as three groups because the responses were analyzed separately, but all participants were part of the single study arm as represented by the remainder of the record. GVAX-specific immune response and Prevnar-specific immune response was assessed in the same patient by using GVAX and Prevnar-specific co-markers.
Time Frame Baseline, Cycle 3 Day 14, end of study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis. Only 8/15 participants experienced complete response (CR), therefore only 8 participants analyzed in the CR rows and 7 participants analyzed in the progressive disease (PD) rows.
Arm/Group Title Pre-vaccine (Baseline) GVAX Vaccine Prevnar Vaccine
Hide Arm/Group Description:
Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).
Allogeneic Myeloma Vaccine: A total of 4 doses will be administered. The first three at monthly intervals and a booster at 6 months from the initial dose. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.
Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: percentage of cells
Complete Response (CR) patients at Baseline Number Analyzed 8 participants 8 participants 8 participants
1.2  (0.4) 0.36  (0.6) 0 [1]   (NA)
CR patients at Cycle 3 Day 14 Number Analyzed 8 participants 8 participants 8 participants
7.3  (2.6) 13.3  (3) 4.54  (2.1)
CR patients at end of Study Number Analyzed 8 participants 8 participants 8 participants
6.3  (1.4) 13.7  (5.1) 3.6  (1.4)
Progressive Disease (PD) patients at Baseline Number Analyzed 7 participants 7 participants 7 participants
0.43  (0.44) 0.45  (0.7) 0 [1]   (NA)
PD patients at Cycle 3 Day 14 Number Analyzed 7 participants 7 participants 7 participants
1.7  (2.9) 5.7  (1.4) 0 [1]   (NA)
PD patients at end of study Number Analyzed 7 participants 7 participants 7 participants
0.4  (0) 0.21  (0) 1.7  (0)
[1]
Mean percentage of CD3+/CSFSE-low/IFN-gamma+ cells was zero, therefore no standard of deviation
Time Frame Up to 1 year
Adverse Event Reporting Description Adverse events were assessed every 28 days.
 
Arm/Group Title Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Hide Arm/Group Description

Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.

Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

All-Cause Mortality
Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Affected / at Risk (%)
Total   0/16 (0.00%)    
Hide Serious Adverse Events
Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Affected / at Risk (%) # Events
Total   1/16 (6.25%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma  1  1/16 (6.25%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide
Affected / at Risk (%) # Events
Total   15/16 (93.75%)    
Cardiac disorders   
Chest pressure  1  1/16 (6.25%)  1
Congestive heart failure  1  2/16 (12.50%)  2
Peripheral edema  1  2/16 (12.50%)  2
Eye disorders   
Interface haze  1  1/16 (6.25%)  1
Gastrointestinal disorders   
Constipation  1  1/16 (6.25%)  2
Diarrhea  1  3/16 (18.75%)  3
Nausea  1  1/16 (6.25%)  1
Pain - mouth  1  1/16 (6.25%)  1
Pain - abdomen  1  1/16 (6.25%)  1
General disorders   
Fatigue  1  3/16 (18.75%)  3
Infections and infestations   
Pneumonia  1  1/16 (6.25%)  1
Upper respiratory infection  1  2/16 (12.50%)  3
Investigations   
Creatinine increased  1  2/16 (12.50%)  2
Musculoskeletal and connective tissue disorders   
Pain - chest wall  1  1/16 (6.25%)  1
Cramping  1  3/16 (18.75%)  3
Pain - knee  1  1/16 (6.25%)  1
Pain - right side  1  1/16 (6.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  1/16 (6.25%)  1
Nervous system disorders   
Dizziness  1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Chest congestion  1  1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
Injection site reactions  1  15/16 (93.75%)  40
Lump - left wrist  1  1/16 (6.25%)  1
Pruritis  1  2/16 (12.50%)  3
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ivan Borrello, MD
Organization: Johns Hopkins University
Phone: 4109554967
EMail: iborrell@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01349569    
Other Study ID Numbers: J1115
NA_00044463 ( Other Identifier: JHMIRB )
First Submitted: May 5, 2011
First Posted: May 6, 2011
Results First Submitted: November 29, 2018
Results First Posted: January 15, 2019
Last Update Posted: January 15, 2019