Personalized Vaccine in Treating Patients With Smoldering Multiple Myeloma

NCT03631043 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 2018-0345NCI-2018-01614
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoldering Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (2)

• Feasibility assessed by the proportion of participants for whom the vaccine is successfully developed and ready to administer

  Within 12 weeks

• Incidence of adverse events

  Up to 12 months

Secondary Outcomes (5)

• Intensity and longevity of antigen specific T-cell mediated immune responses to the neoantigen vaccine

  Up to 12 months

• Time to progression

  Up to 18 months

• Duration of response

  Up to 12 months

• Clinical benefit rate (minor response or better)

  After 6 cycles (168 days)

• Overall survival

  Up to 12 months

Other Outcomes (4)

• Rate of minimal residual disease negativity at complete remission

  Up to 12 months

• Molecular and cellular profiling

  Up to 12 months

• Immunophenotypic analysis

  Up to 12 months

Study Arms (2)

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.

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.

Procedure: Biopsy Specimen Radiography; Drug: Lenalidomide; Biological: Vaccine Therapy

Interventions

Biopsy Specimen Radiography PROCEDURE

Undergo collection of blood and bone marrow

Also known as: Biospecimen Radiography, Specimen Radiography

Stage I (personalized vaccine); Stage II (personalized vaccine, lenalidomide)

Lenalidomide DRUG

Given PO

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Stage II (personalized vaccine, lenalidomide)

Vaccine Therapy BIOLOGICAL

Given personalized vaccine SC

Stage I (personalized vaccine); Stage II (personalized vaccine, lenalidomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Smoldering Multiple Myeloma

Interventions

Lenalidomide; Immunotherapy, Active

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Krina Patel

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 15, 2018
• Study Start: December 21, 2018
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)