Study Stopped
Slow Accrual
Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant
Phase II Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant
2 other identifiers
interventional
2
1 country
1
Brief Summary
The goal of this clinical research study is to learn if vaccinating a donor with your purified myeloma protein and then injecting it back into you will help your immune system control the multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2010
CompletedFirst Submitted
Initial submission to the registry
July 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2017
CompletedResults Posted
Study results publicly available
June 1, 2018
CompletedJune 1, 2018
May 1, 2018
6.6 years
July 30, 2010
March 22, 2018
May 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Rate of Partial Response(PR) and Complete Response(CR) in Patients Receiving DLI From an ID-specific Vaccinated Donor
PR defined as 50% reduction disease including serum monoclonal paraprotein and CR defined as absence of original monoclonal paraprotein in serum and urine.
DLI up to 5 years post DLI
Study Arms (4)
KLH Vaccine (Patient)
EXPERIMENTALAfter DLI on same day, patients receive vaccine according to donor randomization (the same type of vaccine that their donors received).
KLH-id Vaccine (Patient)
EXPERIMENTALAfter DLI on same day, patients receive vaccine according to donor randomization (the same type of vaccine that their donors received).
KLH Vaccine (Donor)
EXPERIMENTALDonor Group 1: (non-specific vaccination) vaccinated with KLH only vaccine 0.5 cc subcutaneously, 3 times on weeks -8, -6 and -2 prior to donor lymphocyte collection.
Vaccine KLH-id (Donor)
EXPERIMENTALDonor Group 2: (myeloma specific vaccination) vaccinated with KLH-id vaccine 0.5 cc subcutaneously, 3 times on weeks -8, -6 and -2 prior to donor lymphocyte collections.
Interventions
Donor: 0.5 cc subcutaneously, 3 times on weeks -8, -6 and -2 prior to lymphocyte collection. Patient: 0.5 cc subcutaneously, 3 times immediately after infusion of donor cells (DLI), and again 4 and 8 weeks post DLI.
Donor: 0.5 cc subcutaneously, 3 times on weeks -8, -6 and -2 prior to donor lymphocyte collection. Patient: 0.5 cc subcutaneously, 3 times immediately after infusion of donor cells (DLI), and again 4 and 8 weeks post DLI.
250 mcg/m2 subcutaneously daily for 4 days after each vaccine
Day 0 (day of lymphocyte collection) donors undergo a steady state pheresis to obtain lymphocytes.
Day 0, infusion to patient of collected donor cells.
Eligibility Criteria
You may qualify if:
- Recipient: Patient with IgG1, IgG2, or IgG4 Multiple Myeloma who has received or planning to receive an allogeneic progenitor cell transplant from a HLA compatible related donor (either 6/6 or 5/6 related donor).
- Recipient: Have evidence of persistent or relapsing disease as demonstrated by persistent serum peak (by either standard protein electrophoresis, immune fixation or free light chain assays) or marrow infiltration. Serum peak must be greater or equal than 0.2 gm/dl and represent more than 70% of the specific immunoglobulin subtype. Patients who have adequate amount of monoclonal idiotype protein previously cryopreserved on prior departmental laboratory protocols are also eligible to be registered for vaccine production using the cryopreserved samples.
- Recipient: Able to sign written informed consent.
- Recipient: Age up to 70 years.
- Recipient: Zubrod PS \>/=2.
- Recipient: Have no serious organ dysfunction as defined by serum creatinine \<2.5 mg/dL, serum bilirubin \<3 x upper limit of normal, SGPT \<4 x upper limit of normal.
- Recipient: Negative donor infectious disease panel: Hepatitis B surface antigen (HBsAg), Anti-Hepatitis B core antibody (HBcAb), Anti-Hepatitis C Virus antibody (HCV Ab), Anti-Human Immunodeficiency Virus (HIV) antibody (HIV 1/2 type O Ab), Anti-Human T cell lymphotrophic Virus (HTLV) antibody (HTLV I/II Ab), Rapid Plasma Reagen (RPR), Cytomegalovirus antibody (CMV), HCV/HIV Nucleic Acid Test, West Nile Virus Nucleic Acid Test, Sickledex, T Cruzi AB. Additional tests shall be performed as required to assess the possibility of transmission of other infectious or non-infectious diseases.
- Recipient: Negative serum Beta HCG test in a women with child bearing potential (not post-menopausal for 12 months or no previous surgical sterilization) and willing to use an effective contraceptive measure while on study. Mothers should not breastfeed during the study.
- Donor: Able to sign written informed consent and be willing to provide donor lymphocytes.
- Donor: Age 18 - 75 years
- Donor: No physical contraindications to lymphocyte collection (i.e. severe atherosclerosis, auto-immune disease, cerebrovascular accident, prior malignancy less than 5 years ago other than non-melanoma skin cancer treated with surgery). Donors with severe atherosclerosis by history will receive a cardiology consult and be judged eligible on a case by case basis.
- Donor: Negative donor infectious disease panel: Hepatitis B surface antigen (HBsAg), Anti-Hepatitis B core antibody (HBcAb), Anti-Hepatitis C Virus antibody (HCV Ab), Anti-Human Immunodeficiency Virus (HIV) antibody (HIV 1/2 type O Ab), Anti-Human T cell lymphotrophic Virus (HTLV) antibody (HTLV I/II Ab), Rapid Plasma Reagen (RPR), Cytomegalovirus antibody (CMV), HCV/HIV Nucleic Acid test. Additional tests shall be performed as required to assess the possibility of transmission of other infectious or non-infectious diseases.
- Donor: Negative serum Beta HCG test in a woman with child bearing potential (not post-menopausal for 12 months or no previous surgical sterilization) must use an effective method of contraception until at least 1 month after lymphocyte collection. Mothers should not breastfeed during the study.
You may not qualify if:
- \) Recipient with IGg3 Multiple Myeloma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Qazilbash,Muzaffar,M.D. / Stem Cell Transplantation
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Muzaffar H. Qazilbash, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 3, 2010
Study Start
July 20, 2010
Primary Completion
February 23, 2017
Study Completion
February 23, 2017
Last Updated
June 1, 2018
Results First Posted
June 1, 2018
Record last verified: 2018-05