This trial is active, not recruiting.

Conditions myeloma, transplant-eligible patients
Treatment autologous ex-vivo expanded effector cells
Phase phase 2
Sponsor Dartmouth-Hitchcock Medical Center
Collaborator The Leukemia and Lymphoma Society
Start date January 2007
End date February 2018
Trial size 20 participants
Trial identifier NCT00439465, D0717, LLS-6061-06


The purpose of this study is to determine whether the administration of highly effective "killer" cells (cytotoxic T cells), along with IL-2 and GM-CSF immediately following Autologous Peripheral Blood Stem Cell Transplantation (APBSCT) will enhance anti-tumor immune reconstitution and improve outcome of Multiple Myeloma patients.

The overall hypothesis of this proposal is that immediately following APBSCT the immune reconstitution is optimal to administer "killer" cells, combined with the administration of IL-2 and GM-CSF.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Infusing IL-2 and GM-CSF post-HCST
autologous ex-vivo expanded effector cells
This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.

Primary Outcomes

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.
time frame: From initiation of treatment on protocol until Day 100

Secondary Outcomes

Identify CD8+ effector cell-versus-myeloma effects in vivo by determining recovery,function& mechanism of tumor cell killing of PB CD8+ cells prior to& after completing therapy.
time frame: From initiation of treatment on protocol until Day 100

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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)

Additional Information

Official title Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
Principal investigator Kenneth Meehan, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center.