Stem Cell Transplant, Chemotherapy, and Biological Therapy in Treating Patients With High-Risk or Refractory Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma and Plasma Cell Neoplasm

In brief

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. A stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving an infusion of the donor's T cells after the transplant may help destroy any remaining cancer cells. PURPOSE: This phase I/II trial is studying the side effects of stem cell transplant given together with chemotherapy and biological therapy and to see how well it works in treating patients with high-risk or refractory multiple myeloma.

Key facts

Study ID

NCT00499577

Run by

University of Maryland Greenebaum Cancer Center

People needed

56

Starts

2006-12-01

Last updated by the study team

2014-01-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status 0-2 (unless due solely to bone pain)
• Creatinine ≤ 3.0 mg/dL and not on dialysis
• WBC ≥ 3,000/mm³
• Platelet count ≥ 100,000/mm³
• AST ≤ 2 times upper limit of normal
• Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome)
• LVEF ≥ 45%
• A lower LVEF is permissible if a formal cardiologic evaluation reveals no evidence for clinically significant functional impairment
• FEV1, FVC, TLC, and DLCO ≥ 40% predicted
• Patients who are unable to complete pulmonary function tests due to bone pain or fracture must have a high-resolution CT scan of the chest and must have acceptable arterial blood gases (room air PO_2 > 70 mmHg)
• Women of child-bearing potential and their spouses or partners must be willing to use adequate contraception for the duration of the active treatment phase of the study
• Contraceptive measures must be continued as long as the patient remains on maintenance thalidomide in accordance with the STEPS program

You may not qualify if…

• Pregnant or nursing
• HIV, HTLV-1/2 seropositivity
• Known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy)
• Active hepatitis B (as defined by positive hepatitis B surface antigen)
• Positive hepatitis C virus (HCV) antibody is NOT an exclusion
• History of severe autoimmune disease requiring steroids or other immunosuppressive treatments
• Active immune-mediated diseases including:
• Connective tissue diseases
• Uveitis
• Sarcoidosis
• Inflammatory bowel disease
• Multiple sclerosis
• Evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease that might increase the risks of participating in the study
• Active bacterial, viral or fungal infections.
• PRIOR CONCURRENT THERAPY:
• Inclusion criteria
• Recovered from any toxicities related to prior therapy or at least returned to their baseline level of organ function
• Patients should be off of glucocorticoids for at least 2 weeks and/or thalidomide therapy for at least 1 week prior to enrollment
• At least 2 weeks since prior steroid therapy or chemotherapy
• Exclusion criteria
• Prior autotransplant or allogeneic transplant
• More than 4 distinct, prior courses of therapy for myeloma
• Also see Disease Characteristics

Where it is running

• Greenebaum Cancer Center at University of Maryland Medical Center — Baltimore, Maryland, United States
• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.