Personalized Vaccine in Treating Patients With Smoldering Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT03631043 |
Recruitment Status :
Recruiting
First Posted : August 15, 2018
Last Update Posted : November 19, 2021
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Condition or disease | Intervention/treatment | Phase |
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Smoldering Plasma Cell Myeloma | Procedure: Biopsy Specimen Radiography Drug: Lenalidomide Biological: Vaccine Therapy | Early Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Personalized Vaccine for the Immune Prevention of Multiple Myeloma |
Actual Study Start Date : | December 21, 2018 |
Estimated Primary Completion Date : | September 30, 2022 |
Estimated Study Completion Date : | September 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Stage I (personalized vaccine)
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.
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Procedure: Biopsy Specimen Radiography
Undergo collection of blood and bone marrow
Other Names:
Biological: Vaccine Therapy Given personalized vaccine SC |
Experimental: Stage II (personalized vaccine, lenalidomide)
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.
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Procedure: Biopsy Specimen Radiography
Undergo collection of blood and bone marrow
Other Names:
Drug: Lenalidomide Given PO
Other Names:
Biological: Vaccine Therapy Given personalized vaccine SC |
- 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 ]
- 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) ]Assessed by the modified International Myeloma Working Group criteria for multiple myeloma.
- Overall survival [ Time Frame: Up to 12 months ]
- Rate of minimal residual disease negativity at complete remission [ Time Frame: Up to 12 months ]Assessed based on bone marrow aspirates.
- Molecular and cellular profiling [ Time Frame: Up to 12 months ]
- Immunophenotypic analysis [ Time Frame: Up to 12 months ]Will assess 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.
- Identification of shared human leukocyte antigen class I-restricted antigens that can be targeted with immunotherapy [ Time Frame: Up to 12 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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
- 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
Exclusion Criteria:
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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)
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Prior or concurrent systemic treatment for SMM
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631043
Contact: Amishi Vora | 832-750-1555 | auvora@mdanderson.org |
United States, Texas | |
M D Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Amishi Vora 832-750-1555 auvora@mdanderson.org | |
Principal Investigator: Elisabet E. Manasanch |
Principal Investigator: | Elisabet E Manasanch | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT03631043 |
Other Study ID Numbers: |
2018-0345 NCI-2018-01614 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0345 ( Other Identifier: M D Anderson Cancer Center ) |
First Posted: | August 15, 2018 Key Record Dates |
Last Update Posted: | November 19, 2021 |
Last Verified: | November 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Multiple Myeloma Neoplasms, Plasma Cell Smoldering Multiple Myeloma 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 Precancerous Conditions Hypergammaglobulinemia Lenalidomide Vaccines Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |