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Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant

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ClinicalTrials.gov Identifier: NCT01174082
Recruitment Status : Terminated (Slow Accrual)
First Posted : August 3, 2010
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Myeloma Biological: KLH Vaccine Biological: KLH-id Vaccine Drug: GM-CSF Procedure: Apheresis Procedure: Donor Lymphocyte Infusion (DLI) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 20, 2010
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: KLH Vaccine (Patient)
After DLI on same day, patients receive vaccine according to donor randomization (the same type of vaccine that their donors received).
Biological: KLH Vaccine

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.


Drug: GM-CSF
250 mcg/m2 subcutaneously daily for 4 days after each vaccine
Other Names:
  • Sargramostim
  • Leukine

Procedure: Donor Lymphocyte Infusion (DLI)
Day 0, infusion to patient of collected donor cells.

Experimental: KLH-id Vaccine (Patient)
After DLI on same day, patients receive vaccine according to donor randomization (the same type of vaccine that their donors received).
Biological: KLH-id Vaccine

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.


Drug: GM-CSF
250 mcg/m2 subcutaneously daily for 4 days after each vaccine
Other Names:
  • Sargramostim
  • Leukine

Procedure: Donor Lymphocyte Infusion (DLI)
Day 0, infusion to patient of collected donor cells.

Experimental: KLH Vaccine (Donor)
Donor 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.
Biological: KLH Vaccine

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.


Drug: GM-CSF
250 mcg/m2 subcutaneously daily for 4 days after each vaccine
Other Names:
  • Sargramostim
  • Leukine

Procedure: Apheresis
Day 0 (day of lymphocyte collection) donors undergo a steady state pheresis to obtain lymphocytes.

Experimental: Vaccine KLH-id (Donor)
Donor 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.
Biological: KLH-id Vaccine

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.


Drug: GM-CSF
250 mcg/m2 subcutaneously daily for 4 days after each vaccine
Other Names:
  • Sargramostim
  • Leukine

Procedure: Apheresis
Day 0 (day of lymphocyte collection) donors undergo a steady state pheresis to obtain lymphocytes.




Primary Outcome Measures :
  1. The Rate of Partial Response(PR) and Complete Response(CR) in Patients Receiving DLI From an ID-specific Vaccinated Donor [ Time Frame: DLI up to 5 years post DLI ]
    PR defined as 50% reduction disease including serum monoclonal paraprotein and CR defined as absence of original monoclonal paraprotein in serum and urine.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Recipient: Able to sign written informed consent.
  4. Recipient: Age up to 70 years.
  5. Recipient: Zubrod PS >/=2.
  6. 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.
  7. 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.
  8. 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.
  9. Donor: Able to sign written informed consent and be willing to provide donor lymphocytes.
  10. Donor: Age 18 - 75 years
  11. 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.
  12. 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.
  13. 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.

Exclusion Criteria:

1) Recipient with IGg3 Multiple Myeloma.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174082


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Muzaffar H. Qazilbash, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01174082     History of Changes
Other Study ID Numbers: 2004-0660
NCI-2012-01781 ( Registry Identifier: NCI CTRP )
First Posted: August 3, 2010    Key Record Dates
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Vaccine
Lymphocyte Infusion

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vaccines
Sargramostim
Immunologic Factors
Physiological Effects of Drugs