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UARK 2003-18, A Phase II Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant in Relapsed Multiple Myeloma


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

UARK 2003-18, A Phase II Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant in Relapsed Multiple Myeloma


This study will induce anti-myeloma responses in patients with high risk or relapsed myeloma
using combination chemo- and immunotherapy comprising sequentially: 1) lymphoid suppressive
conditioning to avoid rejection of the donor NK cells, 2) adoptive transfer of purified
KIR-ligand mismatched Natural Killer cells from a haplo-identical donor, and 3) autografting
two weeks after infusion of NK cells to ensure autologous reconstitution.


Inclusion Criteria:



- MM in frank relapse after a single or tandem transplant or high risk Myeloma

- Patients with prior transplant must be more than 4 months after the last transplant

- Karnofsky performance score >or =70, or a performance score of 50-70 exclusively due
to bone pain caused by myeloma

- 18 years of age or older

- An expected survival greater than 3 months

- ANC >1,000/microliters, platelet count > 100,000/microliters

- Donor and patient must have signed an IRB-approved consent and been informed about
the investigational nature of the study

- Donor must have negative serology for HIV

- Available haplo-identical family donor fit to undergo leukapheresis and mismatched
for KIR-ligand(s) with the patient in the graft-versus host direction.

- Stored cells for autografting of at least 30 million CD34+ cells/kg

- Back-up cells of at least 20 million CD34+ cells/kg in case of non-engraftment.

- There must be an unambiguous marker for response to therapy in the first ten
patients. Therefore the patient must have detectable and quantifiable M-protein or
light chain excretion in urine, light chain quantification in serum (FREELITE) or
clear radiological signal lesion(s) in order to be eligible

- After 10 relapsed patients have been treated and toxicity is deemed acceptable,
high-risk myeloma (defined as the presence of abnormal cytogenetics or metaphase
analysis) patients without relapse can be entered

Exclusion Criteria:

- Intravenous chemotherapy or antibody therapy affecting T-lymphocytes and/or natural
killer cells e.g. cyclophosphamide, melphalan, ATG, Campath-1H etc. within the past 2
weeks prior to commencement of conditioning. Last therapy is less than 14 days prior
to starting fludarabine

- Fever or active infection, requiring IV antibiotics

- Liver function: total bilirubin > 2xULN or AST/ALT >3xULN

- Renal function: patients on dialysis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To induce anti-myeloma responses in patients with high risk or relapsed myeloma using combination chemo- and immunotherapy comprising sequentially.

Outcome Time Frame:

annually

Safety Issue:

No

Principal Investigator

Frits Van Rhee, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas for Medical Sciences/MIRT

Authority:

United States: Food and Drug Administration

Study ID:

UARK 2003-18

NCT ID:

NCT00089453

Start Date:

September 2003

Completion Date:

May 2010

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Transplant
  • Relapsed
  • Donor
  • Stem Cell
  • Thalidomide
  • Dexamethasone
  • Cisplatin
  • Adriamycin
  • Cyclophosphamide
  • Etoposide
  • Melphalan
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical Sciences/MIRTLittle Rock, Arkansas  72205