Donor Lymphocyte Infusion for Myeloma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01174082

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 result in a better response than giving you the cells from a donor that has not received a specific vaccine.

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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Sargramostim

U.S. FDA Resources

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:	48
Study Start Date:	July 2010
Estimated Primary Completion Date:	July 2014 (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:

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.

Exclusion Criteria:

1) Recipient with IGg3 Multiple Myeloma.

Contacts and Locations

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

Contacts

Contact: Muzaffar H. Qazilbash, MD

713-792-8750

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Muzaffar H. Qazilbash, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Muzaffar H. Qazilbash, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01174082 History of Changes
Other Study ID Numbers:	2004-0660
Study First Received:	July 30, 2010
Last Updated:	March 23, 2012
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
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

ClinicalTrials.gov processed this record on May 24, 2012