A Phase 2 interventional study of KLH Vaccine and KLH-id Vaccine in Myeloma, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-01.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
A vaccine will be made of tumor protein taken from your plasma (liquid part of the blood) and KLH (a protein designed to increase the immune response of the vaccine). By vaccinating your brother or sister with protein made from the tumor, researchers hope to increase the antitumor effect of the stem cells. KLH is used to help the immune response.
Study Treatment Schedule:
If you are found to be eligible to take part in this study, you and your brother or sister will receive a vaccine with KLH. This research involves various steps. In Step 1, a large sample of your plasma will be collected through a vein using a blood separator device. This plasma will be sent to the MD Anderson GMP lab to prepare the vaccine. It takes about 3 months to create your myeloma-specific vaccine. It takes about 3 months to prepare enough vaccine for the next phases of the study.
In Step 2, your brother or sister will receive the vaccine with KLH as an injection under the skin 8 weeks, 6 weeks, and 2 weeks before collection of his/her lymphocytes (immune fighting cells). After each injection, your brother or sister will receive an injection of a medication called GM-CSF that helps the body's response to the vaccine. GM-CSF is given under the skin near the site of the vaccination every day for 4 days, starting the day of the vaccination.
In Step 3, your brother or sister will have apheresis. During apheresis, their blood is passed through a "cell separator" and the lymphocytes (immune fighting cells) are collected. A portion of these cells will be given to you on this day. You will get these cells through a vein while the remainder is stored and frozen for research and/or use later on if you fail to respond to the first infusion.
In Step 4, you will receive the vaccine with KLH. It will be given under the skin immediately after you get the infusion of donor cells, and again 4 and 8 weeks after the lymphocyte infusion. After each vaccine, you will receive an injection of a medication called sargramostim (GM-CSF) that helps the body's response to the vaccine. GM-CSF is given under the skin near the site of the vaccination every day for 4 days, starting the day of the vaccination.
If after 6 months you are not responding to the vaccine, you will be allowed to receive 3 additional vaccines, as long as you did not develop graft versus host disease or any other serious side effects to the first vaccine. The vaccines and follow-up schedule is exactly like the first.
Study Visits:
Within 10 days before you receive the infusion of your donor's cells and within 72 hours before each vaccine injection, the following tests and procedures will be performed:
These visits will require 1 day of your time.
Long-Term Follow-Up:
Once a month during Months 3, 6, 12, 18, and 24 months after your last vaccine, the following tests and procedures will be performed:
If you are not able to return to MD Anderson, your study doctor may agree to allow you to have these tests and procedures at your local doctor's office. Your local doctor will need to send the results to research staff at MD Anderson.
Once a year, starting 2 years after you receive the last infusion of your donor's cells, you will be contacted by phone to check on your health status.
Length of Study Participation:
You will be considered off study after 5 years. You will be taken off study at any time if lymphocytes cannot be collected, not enough lymphocytes can be collected, your doctor thinks it is needed, the recipient is not able to receive the vaccine, the study doctor thinks it is in your best interest, you need a treatment that is not allowed while on this study, you are unable to keep appointments, or you have intolerable side effects.
This is an investigational study. The myeloma-specific vaccine is not FDA approved or commercially available, and it has been authorized for use in research only. Up to 10 patients will take part in this study. All will be enrolled at MD Anderson.
3,632 studies on the registry are indexed under Multiple Myeloma; 744 are open to participants now.
This study's enrollment of 2 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 579 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After DLI on same day, patients receive vaccine according to donor randomization (the same type of vaccine that their donors received).
Biological: KLH Vaccine · Drug: GM-CSF · Procedure: Donor Lymphocyte Infusion (DLI)
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 · Drug: GM-CSF · Procedure: Donor Lymphocyte Infusion (DLI)
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 · Drug: GM-CSF · Procedure: Apheresis
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 · Drug: GM-CSF · Procedure: Apheresis
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
Also known as: Sargramostim, Leukine
Day 0 (day of lymphocyte collection) donors undergo a steady state pheresis to obtain lymphocytes.
Day 0, infusion to patient of collected donor cells.
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.
Time frame: DLI up to 5 years post DLI
| Milestone | Recipient | Donor |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
PR defined as 50% reduction disease including serum monoclonal paraprotein and CR defined as absence of original monoclonal paraprotein in serum and urine.
| Participants | Recipient | Donor |
|---|---|---|
| The Rate of Partial Response(PR) and Complete Response(CR) in Patients Receiving DLI From an ID-specific Vaccinated Donor | 1 | 0 |
Collected over Up to 5 years post start of treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Recipient | 1/1 (100%) | 0/1 (0%) | 1/1 (100%) |
| Donor | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Recipient | Donor |
|---|---|---|
| DiarrheaGastrointestinal disorders | 1/1 | 0/1 |
| InfectionInfections and infestations | 1/1 | 0/1 |
| Abd crampingGastrointestinal disorders | 1/1 | 0/1 |
| InsomniaNervous system disorders | 1/1 | 0/1 |
| DizzinessNervous system disorders | 1/1 | 0/1 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/1 | 0/1 |
| FatigueGeneral disorders | 1/1 | 0/1 |
| Decreased PlateletBlood and lymphatic system disorders | 1/1 | 0/1 |
| Skin RashSkin and subcutaneous tissue disorders | 1/1 | 0/1 |
| HemoptysisRespiratory, thoracic and mediastinal disorders | 1/1 | 0/1 |
| Age, Categorical(Participants) | Recipient | Donor | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Recipient | Donor | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Recipient | Donor | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Recipient | Donor | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
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