Graft vs Host DiseasePhase 3NCT00001561
Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation
A Phase 3 study testing Myeloma Immunoglobulin Idiotype Vaccine-KLH and GM-CSF in people with Graft vs Host Disease and Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Both patients and marrow donors are treated on Regimen A; patients then proceed to Regimen B. The following acronyms are used: ABM Allogeneic Bone Marrow BU Busulfan, NSC-750 CF Leucovorin calcium, NSC-3590 CTX Cyclophosphamide, NSC-26271 G-CSF Granulocyte Colony-Stimulating Factor (source not specified) GM-CSF… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Graft vs Host Disease, Multiple Myeloma
- What is being tested?
- Myeloma Immunoglobulin Idiotype Vaccine-KLH and GM-CSF
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1996to Sep 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient Selection:
- Patients with IgG or IgA multiple myeloma who attain at least a PR before transplantation are eligible for thsi protocol.
- Patients may only have received 3-4 courses of VAD, high dose cyclophosphamide and one autologous transplant before entering the study.
- All previous therapy must be completed at least 2 weeks prior to study entry.
- Patients should have recovered from all hematologic and non-hematologic toxicity of previous therapy.
- Steroid must be discontinued at least two weeks prior to vaccination.
Show all 22Show fewer
- Only patients less than 60 years are eligible for this protocol.
- Patients must meet the following criteria:
- Karnofsky performance status greater than or equal to 70 percent.
- Life expectancy greater than 8 weeks and absence of co-existing medical problems which would significantly increase the risk of the transplant procedure in the judgment of the bone marrow transplant attending physicians (e.g., the MUGA left ventricular ejection fraction has to be greater than 50% and DLCO greater thant 50% of the expected value when corrected for Hb).
- Creatinine less than 2x normal and not rising for at least 2-4 weeks before transplantation. If creatinine is elevated, then creatinine clearance must be greater than 40 ml/min.
- Direct bilirubin less than 2 mg/dl, SGOT less than 4x top normal, and none of these parameters increasing, for at least 2-4 weeks before transplantation.
- Patients must be HIV-negative, HBsAg-, and Hepatitis C antibody Negative.
- Not pregnant or lactating. Patients of childbearing potential must use an effective method of contraception.
- M-protein concentration in the harvested plasma must be greater than 90 percent of the total Ig of the corresponding isotype.
- Patients must be greater than or equal to 18 years old.
- Donor criteria:
- Any consenting healthy individual who fulfills the donor criteria will be considered for the marrow donation.
- HLA-identical sibling donors.
- HLA, A and B and DR phenotypically identical family donors.
- HIV, hepatitis B or C seropositive.
- Complete blood count, platelets, and PT, PTT within normal limits.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Both patients and marrow donors are treated on Regimen A; patients then proceed to Regimen B. The following acronyms are used:
ABM Allogeneic Bone Marrow
Read more
BU Busulfan, NSC-750
CF Leucovorin calcium, NSC-3590
CTX Cyclophosphamide, NSC-26271
G-CSF Granulocyte Colony-Stimulating Factor (source not specified)
GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor (Hoechst/Immunex), NSC-613795
GVHD Graft-vs.-Host Disease
Mesna Mercaptoethane sulfonate, NSC-113891
MTX Methotrexate, NSC-740
PP Unconjugated Myeloma Immunoglobulin plasma paraprotein, NSC-684150
PP-KLH Myeloma immunoglobulin plasma paraprotein vaccine, NSC-678327, with keyhole limpet hemocyanin
TBI Total-Body Irradiation
TSPA Thiotepa, NSC-6396
Regimen A (Donor and Patient): Vaccine Therapy with Immunoadjuvant. PP-KLH (individual myeloma immunoglobulin plasma paraprotein vaccine prepared from recipient's plasma paraprotein and conjugated with KLH); and PP; with GM-CSF.
Regimen B (Patient): Myeloablative Radiotherapy and 2-Drug Combination Chemotherapy or 2-Drug Combination Myeloablative Chemotherapy followed by Hematopoietic Rescue with Growth Factor Support and GVHD Prophylaxis followed by Vaccine Therapy with Immunoadjuvant. TBI; and CTX/TSPA; or BU/CTX; followed by ABM; with G-CSF; and CYSP; MTX/CF; followed by PP-KLH; with GM-CSF.
Read the detailed description
Multiple Myeloma remains a largely incurable disease with current therapy. Allogeneic bone marrow transplantation provides an opportunity to add the potential antitumor effect of marrow grafts to those of high dose chemotherapy. One potential strategy for enhancing a graft vs. tumor effect without aggravating graft vs. host disease would be to selectively target an immune response against a defined tumor-specific antigen. The idiotype of the rearranged immunoglobulin gene product of a myeloma can serve as a unique tumor-specific antigen for vaccine development. We are testing the hypothesis that tumor antigen-specific immunity can be adoptively transferred to BMT recipients by active immunization of marrow transplant donors with purified myeloma idiotype protein, conjugated to a carrier protein (KLH) and administered with GM-CSF as an immunological adjuvant.
Patients under age 60 with an HLA-matched sibling donor, with minimal prior treatment, defined by less than six months prior chemotherapy, and who are in a minimal residual disease state prior to allogeneic BMT, as defined by the achievement of at least a PR, are eligible. HLA matched sibling donors receive a series of three vaccinations during an eight week period prior to bone marrow harvest. Recipients concurrently receive vaccinations pre-BMT, as well as three booster vaccinations at weeks 12, 16, and 24 post-BMT. Id-KLH (0.5 mg) is administered s.c. GM-CSF (250 micrograms/m(2)) is administered s.c. locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination. The objective of this protocol is to induce cellular and humoral immunity in marrow transplant donors and recipients against the unique idiotype expressed by the recipient's myeloma.
- Conditions
- Graft vs Host Disease, Multiple Myeloma
- Being tested
- Myeloma Immunoglobulin Idiotype Vaccine-KLH, GM-CSF
- Keywords
- Multiple Myeloma, Vaccine, Idiotype-Specific Immunity, Immune Transfer, Myeloma Immunoglobulin
- Medical subject headings
- Graft vs Host Disease, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myeloma Immunoglobulin Idiotype Vaccine-KLHDrug
GM-CSFDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startNov 1996
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001561
- Sponsor's protocol ID
- 970030
- Other IDs
- 97-C-0030
- Status last verified
- Sep 2005
- First submitted
- 3 Nov 1999
- Last updated
- 24 Sep 2007
- Results posted
- No
Publications
Sirisinha S, Eisen HN. Autoimmune-like antibodies to the ligand-binding sites of myeloma proteins. Proc Natl Acad Sci U S A. 1971 Dec;68(12):3130-5. doi: 10.1073/pnas.68.12.3130.
PubMed 4108872
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT00001561
- Acronym / sponsor ID
- 970030
- Conditions
- Graft vs Host Disease, Multiple Myeloma
- Keywords
- Multiple Myeloma, Vaccine, Idiotype-Specific Immunity, Immune Transfer, Myeloma Immunoglobulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 1996
- Study completion
- Sep 2005
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both patients and marrow donors are treated on Regimen A; patients then proceed to Regimen B. The following acronyms are used:
ABM Allogeneic Bone Marrow
BU Busulfan, NSC-750
CF Leucovorin calcium, NSC-3590
CTX Cyclophosphamide, NSC-26271
G-CSF Granulocyte Colony-Stimulating Factor (source not specified)
GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor (Hoechst/Immunex), NSC-613795
GVHD Graft-vs.-Host Disease
Mesna Mercaptoethane sulfonate, NSC-113891
MTX Methotrexate, NSC-740
PP Unconjugated Myeloma Immunoglobulin plasma paraprotein, NSC-684150
PP-KLH Myeloma immunoglobulin plasma paraprotein vaccine, NSC-678327, with keyhole limpet hemocyanin
TBI Total-Body Irradiation
TSPA Thiotepa, NSC-6396
Regimen A (Donor and Patient): Vaccine Therapy with Immunoadjuvant. PP-KLH (individual myeloma immunoglobulin plasma paraprotein vaccine prepared from recipient's plasma paraprotein and conjugated with KLH); and PP; with GM-CSF.
Regimen B (Patient): Myeloablative Radiotherapy and 2-Drug Combination Chemotherapy or 2-Drug Combination Myeloablative Chemotherapy followed by Hematopoietic Rescue with Growth Factor Support and GVHD Prophylaxis followed by Vaccine Therapy with Immunoadjuvant. TBI; and CTX/TSPA; or BU/CTX; followed by ABM; with G-CSF; and CYSP; MTX/CF; followed by PP-KLH; with GM-CSF.
Detailed description
Multiple Myeloma remains a largely incurable disease with current therapy. Allogeneic bone marrow transplantation provides an opportunity to add the potential antitumor effect of marrow grafts to those of high dose chemotherapy. One potential strategy for enhancing a graft vs. tumor effect without aggravating graft vs. host disease would be to selectively target an immune response against a defined tumor-specific antigen. The idiotype of the rearranged immunoglobulin gene product of a myeloma can serve as a unique tumor-specific antigen for vaccine development. We are testing the hypothesis that tumor antigen-specific immunity can be adoptively transferred to BMT recipients by active immunization of marrow transplant donors with purified myeloma idiotype protein, conjugated to a carrier protein (KLH) and administered with GM-CSF as an immunological adjuvant.
Patients under age 60 with an HLA-matched sibling donor, with minimal prior treatment, defined by less than six months prior chemotherapy, and who are in a minimal residual disease state prior to allogeneic BMT, as defined by the achievement of at least a PR, are eligible. HLA matched sibling donors receive a series of three vaccinations during an eight week period prior to bone marrow harvest. Recipients concurrently receive vaccinations pre-BMT, as well as three booster vaccinations at weeks 12, 16, and 24 post-BMT. Id-KLH (0.5 mg) is administered s.c. GM-CSF (250 micrograms/m(2)) is administered s.c. locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination. The objective of this protocol is to induce cellular and humoral immunity in marrow transplant donors and recipients against the unique idiotype expressed by the recipient's myeloma.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Patients with IgG or IgA multiple myeloma who attain at least a PR before transplantation are eligible for thsi protocol.
- Patients may only have received 3-4 courses of VAD, high dose cyclophosphamide and one autologous transplant before entering the study.
- All previous therapy must be completed at least 2 weeks prior to study entry.
- Patients should have recovered from all hematologic and non-hematologic toxicity of previous therapy.
- Steroid must be discontinued at least two weeks prior to vaccination.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myeloma Immunoglobulin Idiotype Vaccine-KLH | Drug | – |
| GM-CSF | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2007.
- Background: PubMed 4108872Sirisinha S, Eisen HN. Autoimmune-like antibodies to the ligand-binding sites of myeloma proteins. Proc Natl Acad Sci U S A. 1971 Dec;68(12):3130-5. doi: 10.1073/pnas.68.12.3130.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myeloma Immunoglobulin Idiotype Vaccine-KLH and GM-CSF in people with Graft vs Host Disease and Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2007.