Donor Lymphocyte Infusion for Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01174082
First received: July 30, 2010
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogeneic Transplant

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Complete Remission [ Time Frame: 3 months after infusion ] [ Designated as safety issue: No ]
    Efficacy characterized by complete remission (CR).


Estimated Enrollment: 10
Study Start Date: July 2010
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174082

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Muzaffar H. Qazilbash, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01174082     History of Changes
Other Study ID Numbers: 2004-0660, NCI-2012-01781
Study First Received: July 30, 2010
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014