Monoclonal Antibody Therapy and Vaccine Therapy after Stem Cell Transplant in Treating Patients with Multiple Myeloma

Status: closed to accrual

This pilot phase II trial studies how well monoclonal antibody therapy and vaccine therapy after stem cell transplant work in treating patients with multiple myeloma. Immunotherapy with monoclonal antibodies, such as pidilizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill cancer cells. It is not yet known whether giving monoclonal antibody therapy with or without vaccine therapy after stem cell transplant works better in treating patients with multiple myeloma.

Inclusion Criteria

Patients with multiple myeloma who are potential candidates for high dose chemotherapy with stem cell rescue
Patients with measurable disease as defined by a history of an elevated myeloma protein (M component) in plasma, urine, or free kappa/lambda light chains in the serum
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with a greater than nine week life expectancy
Patients with >= 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
Women of childbearing age must have a negative serum pregnancy test, and adequate contraception method(s) must be documented
Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted) > 50%
Cardiac ejection fraction > 45%
White blood cells (WBC) >= 2.0 x 10^3/uL
Bilirubin =< 2.0 mg/dL
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN)
Creatinine =< 2.0 mg/dL
Human immunodeficiency virus (HIV) test must be negative
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
PRIOR TO MOBILIZATION THERAPY: Resolution of grade III-IV toxicity associated with pre-transplant therapy
PRIOR TO HIGH-DOSE CHEMOTHERAPY: Minimum of 2 x10^6 CD34+ cells/kg collected at mobilization
PRIOR TO HIGH-DOSE CHEMOTHERAPY: Patients without evidence of ongoing grade III-IV toxicity related to mobilization therapy
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: Resolution of all transplant related grade III-IV toxicity
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: WBC >= 2.0 X 10^3/uL
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: Platelets > 50,000/uL
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: Bilirubin =< 2.0 mg/dL
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: Creatinine =< 2.0 mg/dL
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: AST/ALT < 3.0 x ULN
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY (COHORT 2): Able to produce at least 2 doses of fusion vaccine to be considered evaluable; patients who are unable to produce at least 2 doses of fusion vaccine, but otherwise meet eligibility criteria for post-transplant immunotherapy, will be treated with pidilizumab (MDV9300) alone and will be replaced

Exclusion Criteria

Patients must not have active or history of clinically significant autoimmune disease, defined as requiring systemic therapy, such as type I diabetes; type II diabetes, vitiligo, stable hypothyroidism, and thyroid disease well controlled with thyroid replacement will not be considered exclusion criteria
Patients who are HIV+ will be excluded
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Pregnant and lactating women will be excluded; all premenopausal patients will undergo pregnancy testing; men will agree to not father a child while on protocol treatment; men and women will practice effective birth control while receiving protocol treatment
History of allogeneic bone marrow/stem cell transplant

PRIMARY OBJECTIVES:

I. To explore immunologic responses to pidilizumab (MDV9300) in the post-transplant period. (Pilot)

II. To determine if cellular immunity is induced by treatment with monoclonal antibody pidilizumab (MDV9300) and dendritic cell (DC)/myeloma fusion cells in conjunction with stem cell transplant. (Phase II)

SECONDARY OBJECTIVES:

I. To assess the toxicity of treating patients with pidilizumab (MDV9300) in the post-transplant setting. (Pilot)

II. To assess the toxicity associated with treating multiple myeloma patients with monoclonal antibody pidilizumab (MDV9300) in combination with DC/myeloma fusion vaccine following autologous transplant. (Phase II)

III. To correlate levels of circulating activated and regulatory T cells with immunologic response. (Phase II)

IV. To define anti-tumor effects using serum markers, radiological studies, and time to disease progression. (Phase II)

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

All patients receive high-dose melphalan intravenously (IV) on days -3 and -2, -2 and -1, or day -2. Patients then undergo autologous hematopoietic stem cell transplant on day 0.

COHORT I: Beginning 1-3 months after autologous stem cell transplant, patients receive pidilizumab IV over 2-10 hours on days 1, 43, and 85.

COHORT II: Beginning 1-3 months after autologous stem cell transplant, patients receive 2-3 doses of DC/myeloma fusion cell vaccine subcutaneously (SC) on days 1, 43, and/or 85. Patients also receive pidilizumab IV over 2-10 hours on days 8, 51, and 93. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at least monthly for 6 months, every 3 months for 3 years, and yearly thereafter.

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Monoclonal Antibody Therapy and Vaccine Therapy after Stem Cell Transplant in Treating Patients with Multiple Myeloma

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