Refractory Multiple MyelomaPhase 1NCT00002787
Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation
A Phase 1 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine, sargramostim and aldesleukin in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium at 1 site in United States.
Trial summary
The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma
- What is being tested?
- autologous immunoglobulin idiotype-KLH conjugate vaccine, sargramostim and aldesleukin
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1996to Dec 2002
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ELIGIBILITY FOR VACCINE PREPARATION:
- Patients must have a diagnosis of multiple myeloma and be eligible for a Fred Hutchinson Cancer Research Center (FHCRC) treatment protocol using high dose therapy with syngeneic, allogeneic or autologous marrow or stem cell transplantation
- Pretransplant sera available with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE), immunoglobulin G (IgG), or immunoglobulin M (IgM) monoclonal paraprotein with a level of 1.5 grams/dl or greater identifiable on serum protein electrophoresis; eligibility for patients with pretransplant paraprotein levels of less than 1.5 gm/dl will be evaluated on an individual basis to determine whether purification of idiotype is feasible
- ELIGIBILITY FOR POST-TRANSPLANT IDIOTYPE VACCINATION:
- Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera
- Greater than 60 days post BMT
Show all 15Show fewer
- Achievement of a partial remission or greater (more than 75% reduction in serum paraprotein) for patients transplanted in relapse
- Stable absolute neutrophil count (ANC) > 1000
- Platelet count > 50,000 not requiring transfusions or growth factors
- Red blood cell (RBC) supportable to hematocrit (Hct) > 25 with less than 2 units of packed red blood cell (PRBC)/week
- Treatment with a stable dose of Interferon is allowed
- Karnofsky status > 60 percent
- Immunosuppression:
- Off all corticosteroids
- Either off all immunosuppressive medications or on a stable/tapering dose of cyclosporin or FK506 only
Who cannot join
- Graft-vs-host disease requiring treatment with corticosteroids
- Serum creatinine > 3.0
- Uncontrolled infection
- Disease progression
- Presence of medical complication that in the opinion of the investigators would result in inability to tolerate the vaccination protocol
- Patients with a history of serious adverse reactions to GM-CSF
- Patients with a history of serious adverse reactions to IL-2 will not receive concurrent IL-2 administration but may receive the Id-KLH vaccine with GM-CSF
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation
The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety of multiple subcutaneous vaccinations with myeloma Id-KLH (idiotype-keyhole limpet hemocyanin) with GM-CSF (sargramostim) in post allogeneic transplant myeloma patients, or with GM-CSF +/- interleukin (IL)-2 (aldesleukin) in post autologous transplant myeloma patients.
II. To evaluate patients pre and post bone marrow transplantation (BMT) for evidence of endogenous idiotype specific immune response.
III. To characterize the time course, specificity and persistence of antibody and T cell immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization.
IV. To clone, expand and characterize T cells specific for the tumor idiotype. V. Monitor myeloma involvement in bone marrow and serum paraprotein level following vaccination.
VI. Use stored patient samples to clone, expand, and characterize T cells specific for myeloma antigens other than idiotype and identify the antigens they recognize so that they can be used in future studies.
OUTLINE:
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim subcutaneously (SC) in weeks 0, 2, 6, and 10 and sargramostim SC once daily (QD) for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 1 year.
- Conditions
- Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Being tested
- autologous immunoglobulin idiotype-KLH conjugate vaccine, sargramostim, aldesleukin, laboratory biomarker analysis
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous immunoglobulin idiotype-KLH conjugate vaccineBiological
Also called autologous immunoglobulin idiotype-keyhole limpet hemocyanin conjugate vaccine, GTOP-99, Id-KLH, Id-KLH conjugate vaccine
Given SC
sargramostimBiological
Also called GM-CSF, Leukine, Prokine
Given SC
aldesleukinBiological
Also called IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2
Given SC
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (vaccine therapy) | Experimental | Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14. Receives: Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine; Biological: sargramostim; Biological: aldesleukin; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
Measured: Up to 2 years
Immune response
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2004 (estimated)
- Study startMar 1996
- Primary completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Multiple MyelomaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David Maloney, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002787
- Sponsor's protocol ID
- 1104.00
- Other IDs
- NCI-2012-00669
- Status last verified
- May 2019
- First submitted
- 1 Nov 1999
- Last updated
- 6 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00002787
- Acronym / sponsor ID
- 1104.00
- Conditions
- Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1996
- Primary completion
- Dec 2002 (actual)
- First posted
- 21 May 2004 (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.
The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety of multiple subcutaneous vaccinations with myeloma Id-KLH (idiotype-keyhole limpet hemocyanin) with GM-CSF (sargramostim) in post allogeneic transplant myeloma patients, or with GM-CSF +/- interleukin (IL)-2 (aldesleukin) in post autologous transplant myeloma patients.
II. To evaluate patients pre and post bone marrow transplantation (BMT) for evidence of endogenous idiotype specific immune response.
III. To characterize the time course, specificity and persistence of antibody and T cell immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization.
IV. To clone, expand and characterize T cells specific for the tumor idiotype. V. Monitor myeloma involvement in bone marrow and serum paraprotein level following vaccination.
VI. Use stored patient samples to clone, expand, and characterize T cells specific for myeloma antigens other than idiotype and identify the antigens they recognize so that they can be used in future studies.
OUTLINE:
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim subcutaneously (SC) in weeks 0, 2, 6, and 10 and sargramostim SC once daily (QD) for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (vaccine therapy) | Experimental | Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine, Biological: sargramostim, Biological: aldesleukin, Other: laboratory biomarker analysisPatients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- ELIGIBILITY FOR VACCINE PREPARATION:
- Patients must have a diagnosis of multiple myeloma and be eligible for a Fred Hutchinson Cancer Research Center (FHCRC) treatment protocol using high dose therapy with syngeneic, allogeneic or autologous marrow or stem cell transplantation
- Pretransplant sera available with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE), immunoglobulin G (IgG), or immunoglobulin M (IgM) monoclonal paraprotein with a level of 1.5 grams/dl or greater identifiable on serum protein electrophoresis; eligibility for patients with pretransplant paraprotein levels of less than 1.5 gm/dl will be evaluated on an individual basis to determine whether purification of idiotype is feasible
- ELIGIBILITY FOR POST-TRANSPLANT IDIOTYPE VACCINATION:
- Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera
Key exclusion criteria (7 listed)
- Graft-vs-host disease requiring treatment with corticosteroids
- Serum creatinine > 3.0
- Uncontrolled infection
- Disease progression
- Presence of medical complication that in the opinion of the investigators would result in inability to tolerate the vaccination protocol
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 |
|---|---|---|
| autologous immunoglobulin idiotype-KLH conjugate vaccineAlso: autologous immunoglobulin idiotype-keyhole limpet hemocyanin conjugate vaccine, GTOP-99, Id-KLH, Id-KLH conjugate vaccineGiven SC | Biological | Treatment (vaccine therapy) |
| sargramostimAlso: GM-CSF, Leukine, ProkineGiven SC | Biological | Treatment (vaccine therapy) |
| aldesleukinAlso: IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2Given SC | Biological | Treatment (vaccine therapy) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (vaccine therapy) |
Primary outcome
Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria
Time frame: Up to 2 years
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
Immune response
Time frame: Up to 2 years
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
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 6 May 2019.
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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.
David Maloney principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine, sargramostim and aldesleukin in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium 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 15 inclusion and 7 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 6 May 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2019.