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Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Myeloma, Transplant-eligible Patients

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Trial Information

Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma


Inclusion Criteria:



Multiple Myeloma:

- Patients must meet criteria for diagnosis of Multiple Myeloma.

- Patient must meet either criterion listed below:

- Stage I, II, or III newly diagnosed multiple myeloma

- Progressive or relapsed disease in PR or CR

- Primary refractory disease.

- Relapsed refractory disease.

- Patients may have received a prior autologous transplant.

- The patients must have recovered from all serious and life threatening effects of
previous treatment at the time of study entry (unless this abnormality is believed to
be due to the underlying myeloma).

- The patient must have adequate bone marrow function, i.e. a total WBC of > 2,000/ul,
a Hgb of > 7 gm/dl, and a platelet count of > 50,000/ul, unless this abnormality is
believed to be due to the underlying myeloma.

- The patient must have adequate liver function, i.e. bilirubin <2.0 mg/dl, SGOT, SGPT
not greater than 2 times the upper normal limit (unless this abnormality is believed
to be due to the underlying myeloma).

- The patient must have adequate renal function, i.e. serum creatinine < 3.0 mg/dl,
and/or creatinine clearance >50 ml/min. This eligibility criterion is excluded if
renal insufficiency is believed to be secondary to myeloma.

- Age >18 years and < 75 years old

- The patient must have a Karnofsky status > 80%

- Patients must have a life expectancy of at least 12 weeks

- Left ventricular ejection fraction of > 45% by radionuclide scan or echocardiography

- Pulmonary function tests: forced vital capacity, DLCO and FEV1 must be > 50% of
predicted

- No significant co-morbid medical or psychiatric illness which would significantly
compromise the patient's clinical care and chances of survival.

- Informed written consent must be obtained. Patients must be able to give informed
consent as a prerequisite to this procedure. The Informed Consent form will become
part of his/her permanent record and a copy will be given to the patient

Exclusion Criteria:

- Medical, social, or psychological factors which would prevent the patient from
receiving or cooperating with the full course of therapy.

- Evidence on physical exam, LP, CT, or MRI scan of CNS involvement with malignancy

- Any clinically significant cardiac disease (angina, myocardial infarction, congestive
heart failure, ventricular arrhythmias requiring therapy) or clinically significant
obstructive/restrictive pulmonary disease

- Serology positive for HIV or HTLVI

- Active hepatitis B or C

- History of seizures

- Concurrent or expected need for therapy with corticosteroids

- Active connective tissue disease

- Current "clinically significant" pleural effusion, pericardial effusion, or ascites

- Positive pregnancy test or presence of lactation

- Collection of fewer than 1 x 106 CD34+ cells/kg (peripheral blood stem cells). If the
apheresis collection is inadequate based on this criteria, the patient will be
removed from protocol and a marrow harvest may be performed

- A history of a second malignancy (other then squamous cell/ basal cell carcinoma of
the skin or cervical dysplasia) must be reviewed by the Principal Investigator,
before inclusion or exclusion in the study. Based upon the PI's review, this patient
may be eligible (i.e., distant past history of a malignancy)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the safety (toxicity), time to engraftment and clinical outcomes of myeloma patients treated with high dose melphalan, APBSCT& adoptive transfer of cytotoxic effector cells with IL-2 and GM-CSF.

Outcome Time Frame:

From initiation of treatment on protocol until Day 100

Safety Issue:

Yes

Principal Investigator

Kenneth Meehan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

D0717

NCT ID:

NCT00439465

Start Date:

January 2007

Completion Date:

December 2014

Related Keywords:

  • Myeloma
  • Transplant-eligible Patients
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756