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Expanded Natural Killer (NK) Cells for Multiple Myeloma Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01040026
First received: December 23, 2009
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

High-dose chemotherapy with melphalan and autologous hematopoietic stem cell transplantation (HSCT) is considered standard treatment for patients with multiple myeloma. While autologous HSCT may induce remission in patients resistant to standard chemotherapy, and has been shown to lead to long-lasting disease control in a subgroup of patients, the procedure is not curative. Given enough time and in the absence of a competing cause of death, all patients eventually relapse after auto-HSCT.

The only potentially curative approach currently available in the treatment of multiple myeloma (MM) is stem cell trans-plantation from an allogeneic donor. Allogeneic HSCT eradicates residual myeloma cells through T-cell mediated graft-versus-tumor effects. Allogeneic HSCT is, however, associated with significant risk of graft-versus-host disease and its use is therefore limited to younger patients with high risk dis-ease. Malignant plasma cells in multiple myeloma are also sensitive to natural killer cell lysis. Natural killer cells do not cause graft-versus-host disease, which has led to interest in their therapeutic use in patients with multiple myeloma.

We have previously shown that immunomagnetic separation of a highly pure NK cell product from a leukapheresis is possible and that these cells can be expanded up to 100-fold in a GMP-compatible setting. The current study aims to test the tolerability and feasibility of infusions of in vitro expanded haploidentical NK cells for patients after melphalan 200mg/m2 high dose chemotherapy and autologous HSCT in 10 patients. If feasible, the data will provide a basis for further prospective studies.


Condition Intervention Phase
Multiple Myeloma
Other: Treatment with in vitro expanded haploidentical NK cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Single Center Study to Assess Tolerability and Feasibility of Infusions of Allogeneic Expanded Haploidentical Natural Killer (NK) Cells in Patients Treated With High Dose Melphalan Chemotherapy and Autologous Stem Cell Transplantation for a Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Safety of expanded NK cell infusion [ Time Frame: One year after infusion. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment efficacy [ Time Frame: One year after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: December 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NK cell infusions
10 NK cell infusions day 3-30; Treatment with in vitro expanded haploidentical NK cells
Other: Treatment with in vitro expanded haploidentical NK cells
10 expanded NK-DLI will be applied at fixed intervals and to each patient within 30 days (3 applications per week, Mo/We/Fr) starting with increasing CD56+CD3- NK cell doses at 3 dose levels (1.5x10e6/kg, 1.5x10e7/kg and 1x10e8/kg) and, if safe, continuing with maximally 7 doses of 1x10e8/kg. Maximal cumulative T-cell dose is fixed at <1x10e5/kg

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years, with multiple myeloma and indication for an autologous HSCT
  • Available related haploidentical donor
  • Written informed consent

Exclusion Criteria:

  • Patients scheduled for autologous/allogeneic tandem HSCT
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040026

Contacts
Contact: Martin Stern, MD 41 61 328 73 90 martin.stern@usb.ch

Locations
Switzerland
University Hospital Recruiting
Basel, BS, Switzerland, 4031
Contact: Martin Stern, MD    41 61 328 73 90    sternm@uhbs.ch   
Principal Investigator: Martin Stern, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Martin Stern, MD Dep. of Hematology, Petersgraben 4, CH-4031 Basel
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01040026     History of Changes
Other Study ID Numbers: NK_MM_01
Study First Received: December 23, 2009
Last Updated: August 19, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014