Smoldering Plasma Cell MyelomaEarly Phase 1NCT03631043
Personalized Vaccine in Treating Patients With Smoldering Multiple Myeloma
A Early Phase 1 study testing Biopsy Specimen Radiography, Lenalidomide and Vaccine Therapy in people with Smoldering Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This early phase I trial studies the side effects of personalized vaccine in treating patients with smoldering multiple myeloma. Vaccines made from a person's blood and bone marrow may help the body build an effective immune response to kill cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoldering Plasma Cell Myeloma
- What is being tested?
- Biopsy Specimen Radiography, Lenalidomide and Vaccine Therapy
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2018to 10 Dec 2025
- Phase
- Early 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with intermediate or high-risk smoldering multiple myeloma (SMM) are eligible
- Patients must have histologically confirmed SMM based on the following criteria. Both criteria must be met: (a) Serum monoclonal protein (IgG or IgA) >= 3 g/dL or urinary monoclonal protein >=500 mg per 24 hours and/or clonal bone marrow plasma cells more or equal to 10% (b) Absence of myeloma defining events or amyloidosis
- Additionally, patients must meet criteria for intermediate or high risk of progression to multiple myeloma by Programa para el Estudio de la Terapeutica en Hemopatía Maligna (PETHEMA) criteria (patients must have at least 1 risk factors present):
- >= 95% abnormal plasma cells/total plasma cells in bone marrow compartment. (This is measured as a percentage of the total abnormal versus normal plasma cells in the bone marrow compartment using standard flow cytometry of the bone marrow aspirate. Having >= 95% abnormal plasma cells/total plasma cells constitutes a risk factor for progression to multiple myeloma by PETHEMA criteria)
- Immunoparesis (The patient having low uninvolved immunoglobulins in peripheral blood, for example if a patient has IgA smoldering multiple myeloma, then either having a low IgM and/or low IgG will qualify as a risk factor for progression to multiple myeloma) *1 of 2 risk factors: intermediate risk for progression at a rate of ~50% at 5 years *2 of 2 risk factors: high risk for progression at a rate of 72% at 5 years
- Creatinine clearance >= 40 ml/min using the modification of diet in renal disease (MDRD) equation
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
- Hemoglobin >= 10 g/dL
- Platelet count >= 50 x 10^9/L
- Platelet and blood transfusions are allowed on protocol. Growth factors, including granulocyte colony stimulating factors and erythropoietin are allowed
- Bilirubin < 1.5 x the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x ULN
- Subjects must be able to give informed consent
Who cannot join
- Evidence of myeloma defining events due to underlying plasma cell proliferative disorder meeting at least one of the following
- Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)
- Renal Insufficiency: creatinine clearance < 40 ml/min or serum creatinine > 2 mg/dL
- Anemia: hemoglobin value < 10 g/dL
- Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2[F-18] fluoro-D-glucose positron emission tomography CT (PET-CT)
- Prior or concurrent systemic treatment for SMM
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- Bisphosphonates are permitted
- Treatment with corticosteroids is not permitted (allowed for physiologic doses)
- Radiotherapy is not permitted
- Prior treatment for smoldering multiple myeloma with chemotherapy agents approved for the treatment of multiple myeloma is not permitted
- Plasma cell leukemia
- Pregnant or lactating females
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Has a known history of active TB (Bacillus tuberculosis)
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- Has an active infection requiring systemic therapy
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 60 days after the last dose of trial treatment
- Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
- Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Personalized Vaccine for the Immune Prevention of Multiple Myeloma
This early phase I trial studies the side effects of personalized vaccine in treating patients with smoldering multiple myeloma. Vaccines made from a person's blood and bone marrow may help the body build an effective immune response to kill cancer cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To demonstrate that developing a custom vaccine for smoldering multiple myeloma (SMM) is feasible.
II. To show that a custom peptide-based vaccine in smoldering multiple myeloma is safe.
SECONDARY OBJECTIVES:
- To determine the intensity and longevity of antigen specific T-cell mediated immune responses to the neoantigen vaccine.
II. Time to progression to multiple myeloma (TTM) at the end of the follow up period (18 months).
III. Duration of response. IV. Clinical benefit rate (minor response [MR] or better) after 6 cycles of vaccine treatment per modified International Myeloma Working Group (IMWG) criteria for multiple myeloma (MM).
- Overall survival.
EXPLORATORY OBJECTIVES:
- Rate of minimal residual disease (MRD) negativity at complete remission (CR), if achieved. MRD assessment will be based on bone marrow aspirates.
II. Molecular profiling (including whole exome sequencing, gene expression profiling and ribonucleic acid (RNA) sequencing of tumor/bone marrow samples) and cellular (including flow cytometry) profiling at baseline using bone marrow aspirate samples and peripheral blood.
III. Immunophenotypic characterization of dendritic, T-, B-, natural killer (NK)- and NKT-cells, and inhibitory/activation markers on tumor cells at baseline (bone marrow and peripheral blood), day 1 of each cycle (peripheral blood only) and at completion of 6 cycles of therapy (bone marrow and peripheral blood) in bone marrow aspirate samples and/or peripheral blood.
IV. Perform mass spectrometry-based proteomics analysis on 15 myeloma cell lines to identify shared human leukocyte antigen (HLA) class I-restricted antigens that can be targeted with immunotherapy.
OUTLINE: Patients are assigned to 1 of 2 stages.
STAGE I: Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine subcutaneously (SC) on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
STAGE II: Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Patients also receive lenalidomide orally (PO) on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 12 months.
- Conditions
- Smoldering Plasma Cell Myeloma
- Being tested
- Biopsy Specimen Radiography, Lenalidomide, Vaccine Therapy
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy Specimen RadiographyProcedure or surgery
Also called Biospecimen Radiography, Specimen Radiography
Undergo collection of blood and bone marrow
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given PO
Vaccine TherapyBiological
Given personalized vaccine SC
| Study group | Role | What they receive |
|---|---|---|
| Stage I (personalized vaccine) | Experimental | Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Biopsy Specimen Radiography; Biological: Vaccine Therapy |
| Stage II (personalized vaccine, lenalidomide) | Experimental | Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Biopsy Specimen Radiography; Drug: Lenalidomide; Biological: Vaccine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by the proportion of participants for whom the vaccine is successfully developed and ready to administer
Measured: Within 12 weeks
Incidence of adverse events
Measured: Up to 12 months
Secondary outcomes (5)
Intensity and longevity of antigen specific T-cell mediated immune responses to the neoantigen vaccine
Measured: Up to 12 months
Time to progression
Measured: Up to 18 months
Duration of response
Measured: Up to 12 months
Clinical benefit rate (minor response or better)
Assessed by the modified International Myeloma Working Group criteria for multiple myeloma.
Measured: After 6 cycles (168 days)
Overall survival
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start21 Dec 2018
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoldering Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krina Patel, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631043
- Sponsor's protocol ID
- 2018-0345
- Other IDs
- NCI-2018-01614, 2018-0345
- Status last verified
- Dec 2025
- First submitted
- 10 Aug 2018
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Vaccine for the Immune Prevention of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03631043
- Acronym / sponsor ID
- 2018-0345
- Conditions
- Smoldering Plasma Cell Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 15 Aug 2018 (actual)
- 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.
This early phase I trial studies the side effects of personalized vaccine in treating patients with smoldering multiple myeloma. Vaccines made from a person's blood and bone marrow may help the body build an effective immune response to kill cancer cells.
Detailed description
PRIMARY OBJECTIVES:
- To demonstrate that developing a custom vaccine for smoldering multiple myeloma (SMM) is feasible.
II. To show that a custom peptide-based vaccine in smoldering multiple myeloma is safe.
SECONDARY OBJECTIVES:
- To determine the intensity and longevity of antigen specific T-cell mediated immune responses to the neoantigen vaccine.
II. Time to progression to multiple myeloma (TTM) at the end of the follow up period (18 months).
III. Duration of response. IV. Clinical benefit rate (minor response [MR] or better) after 6 cycles of vaccine treatment per modified International Myeloma Working Group (IMWG) criteria for multiple myeloma (MM).
- Overall survival.
EXPLORATORY OBJECTIVES:
- Rate of minimal residual disease (MRD) negativity at complete remission (CR), if achieved. MRD assessment will be based on bone marrow aspirates.
II. Molecular profiling (including whole exome sequencing, gene expression profiling and ribonucleic acid (RNA) sequencing of tumor/bone marrow samples) and cellular (including flow cytometry) profiling at baseline using bone marrow aspirate samples and peripheral blood.
III. Immunophenotypic characterization of dendritic, T-, B-, natural killer (NK)- and NKT-cells, and inhibitory/activation markers on tumor cells at baseline (bone marrow and peripheral blood), day 1 of each cycle (peripheral blood only) and at completion of 6 cycles of therapy (bone marrow and peripheral blood) in bone marrow aspirate samples and/or peripheral blood.
IV. Perform mass spectrometry-based proteomics analysis on 15 myeloma cell lines to identify shared human leukocyte antigen (HLA) class I-restricted antigens that can be targeted with immunotherapy.
OUTLINE: Patients are assigned to 1 of 2 stages.
STAGE I: Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine subcutaneously (SC) on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
STAGE II: Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Patients also receive lenalidomide orally (PO) on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage I (personalized vaccine) | Experimental | Procedure: Biopsy Specimen Radiography, Biological: Vaccine TherapyPatients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Stage II (personalized vaccine, lenalidomide) | Experimental | Procedure: Biopsy Specimen Radiography, Drug: Lenalidomide, Biological: Vaccine TherapyPatients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult patients with intermediate or high-risk smoldering multiple myeloma (SMM) are eligible
- Patients must have histologically confirmed SMM based on the following criteria. Both criteria must be met: (a) Serum monoclonal protein (IgG or IgA) >= 3 g/dL or urinary monoclonal protein >=500 mg per 24 hours and/or clonal bone marrow plasma cells more or equal to 10% (b) Absence of myeloma defining events or amyloidosis
- Additionally, patients must meet criteria for intermediate or high risk of progression to multiple myeloma by Programa para el Estudio de la Terapeutica en Hemopatía Maligna (PETHEMA) criteria (patients must have at least 1 risk factors present):
- Creatinine clearance >= 40 ml/min using the modification of diet in renal disease (MDRD) equation
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (21 listed)
- Evidence of myeloma defining events due to underlying plasma cell proliferative disorder meeting at least one of the following
- Prior or concurrent systemic treatment for SMM
- Plasma cell leukemia
- Pregnant or lactating females
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
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 |
|---|---|---|
| Biopsy Specimen RadiographyAlso: Biospecimen Radiography, Specimen RadiographyUndergo collection of blood and bone marrow | Procedure or surgery | Stage I (personalized vaccine), Stage II (personalized vaccine, lenalidomide) |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven PO | Drug | Stage II (personalized vaccine, lenalidomide) |
| Vaccine TherapyGiven personalized vaccine SC | Biological | Stage I (personalized vaccine), Stage II (personalized vaccine, lenalidomide) |
Primary outcome
Feasibility assessed by the proportion of participants for whom the vaccine is successfully developed and ready to administer
Time frame: Within 12 weeks
Incidence of adverse events
Time frame: Up to 12 months
5 secondary outcomes
Intensity and longevity of antigen specific T-cell mediated immune responses to the neoantigen vaccine
Time frame: Up to 12 months
Time to progression
Time frame: Up to 18 months
Duration of response
Time frame: Up to 12 months
Clinical benefit rate (minor response or better)
Time frame: After 6 cycles (168 days)
Overall survival
Time frame: Up to 12 months
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 19 Dec 2025.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Smoldering Plasma Cell Myeloma
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The Indiana Myeloma Registry
Plasma Cell Dyscrasias
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Screening for AL Amyloidosis in Smoldering Multiple Myeloma
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Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma
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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.
Krina Patel principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biopsy Specimen Radiography, Lenalidomide and Vaccine Therapy in people with Smoldering Plasma Cell Myeloma, run by M.D. Anderson Cancer Center 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 14 inclusion and 21 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 19 Dec 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Feasibility assessed by the proportion of participants for whom the vaccine is successfully developed and ready to administer (time frame: Within 12 weeks). 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 19 Dec 2025.