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Investigator(s):
Claude Sportès, M.D. Principal Investigator Phone: 301-435-5280 Fax: 301-402-7515 csportes@mail.nih.gov
Referral Contact(s):
Zetta Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-451-5578 bblacklock@mail.nih.gov	Sheila Phang, R.N., M.S. Research Nurse Phone: 301-435-9379 Fax: 301-451-5578 sphang@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed diagnosis of multiple myeloma (MM)
• Stage II and III of the International Staging System
• Must be eligible for planned high-dose chemotherapy (consisting of melphalan only)
• ≥ 18 years and ≤ 75 years of age
• Karnofsky performance status of ≥ 70 percent (ECOG ≤ 1)
• Criteria for newly or recently diagnosed patients
  • Presence of clonal plasma cells in the bone marrow > 10 percent or a documented clonal plasmacytoma
  • Presence of an M-component (IgG or IgA) > 3g/dL in serum or > 200 mg/24 h in urine (in the absence of an M-component—an abnormal serum free light chain (FLC) ratio on the serum FLC assay)
  • Presence of one or more of the following attributable to the disease:
    • Calcium elevation > 11.5 mg/dL (2.65 mmol/L)
    • Renal insufficiency: serum creatinine greater than 2 mg/dL (177 mmol/L)
    • Hemoglobin < 10g/dL (12.5 mmol/L) or 2 g/dL (1.25 mmol/L) below lower normal
    • Bone disease (lytic lesions or osteopenia)
    • Other evidence of disease activity, including repeated infections, secondary amyloidosis, hyperviscosity, hypogammablobulinemia
  • Received no more than 6 cycles of induction therapy for MM
• Criteria for patients with persistent or recurrent MM
  • Recurrent or persistent evaluable disease, regardless of the high-risk status at the time of diagnosis
  • Has not undergone autologous stem cell transplant (ASCT) for the treatment of the myeloma

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Study Outline:

• Early in the treatment plan for newly diagnosed multiple myeloma or at the time of disease progression, the patient visits the NIH Clinical Center (for enrollment on study and lymphapheresis)
• The patient may return to their physician for initiation (or completion) of induction chemotherapy; stem cell mobilization and collection; high-dose chemotherapy; and autologous stem cell transplant (ASCT)
• Any part of the standard-of-care therapy may be administered at the NIH Clinical Center under the care of the study investigator, if so desired by the primary physician and the patient
• Approximately 6 weeks after ASCT, the patients return to the NIH Clinical Center for Th1 cell infusion (short inpatient stay at the NIH Clinical Center)
• The patients will have regular follow-up visits at NIH Clinical Center

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/6/12
Updated: 10/19/11