Status:
COMPLETED
Treated T Cells Followed by a Stem Cell Transplant in Treating Patients With Multiple Myeloma
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Giving chemotherapy followed by treated T cells before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. After treatment, stem cells...
Detailed Description
OBJECTIVES: Primary * To test the feasibility and safety of infusing anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells (CD20Bi-AATC) before stem cell mobilization and collection for a...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
- Candidate for high-dose chemotherapy and autologous stem cell transplantation
- No definite morphologic evidence of myelodysplasia on pretreatment bone marrow
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 70-100%
- ANC \> 500/mm\^3
- Platelet count ≥ 75,000/mm\^3
- Total bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 3 times upper limit of normal
- Creatinine ≤ 2.0 mg/dL
- LVEF ≥ 45%
- Corrected pulmonary diffusion capacity ≥ 50%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infections or other severe medical problems such as adrenal dysfunction
- No other active malignancy (except for nonmelanoma skin cancer) that requires myelosuppressive chemotherapy or radiotherapy
- No HIV infection
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- On-chemotherapy induction with thalidomide or lenalidomide with dexamethasone is allowed
- No prior stem cell transplantation
- No more than 2 prior treatment regimens (including the one during which patients undergo leukapheresis for T-cells)
- No more than 4 courses of lenalidomide in combination with other agents or as a single agent over a 1-year period
- No other concurrent immunotherapy, radiotherapy, chemotherapy, or anti-myeloma therapy at the time of the anti-CD3 x anti-CD20-armed ATC infusion
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00938626
Start Date
October 1 2009
End Date
March 1 2013
Last Update
September 23 2013
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379