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A Phase II Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Asymptomatic Multiple Myeloma

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Trial Information

A Phase II Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma


To determine whether significant in vivo expansion of auto-ENK cells occurs, defined as a >
4 fold increase in absolute cluster of differentiation 3(CD3)-cluster of differentiation 56
(CD56+) NK cell count/blood 7 days after infusion over the pre-study baseline level and the
safety of the ENK cell therapy in research participants with high-risk asymptomatic multiple
myeloma (AMM) defined as gene expression profile (GEP) 70 gene score>-0.26.


Inclusion Criteria:



- The study population will be participants with AMM being seen at Myeloma Institute
for Research and Therapy (MIRT), and under continuing followup with standard clinical
care testing .

- Participants must have a diagnosis of AMM as defined in Staging Criteria (Section
3.0) and GEP-70 score >-0.26.

- Participant (male or female) from any race or ethnicity must be at least 18 years of
age and not older than 75 years of age at the time of registration.

- Participants must have a performance status of 0 - 2 by Zubrod criteria

- Participants must have signed an Institutional Review Board (IRB)-approved informed
consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
form.

- Must be fit to undergo leukapheresis for ENK cell generation as determined by PI.

- Must be a suitable candidate for insertion of apheresis catheter. Participants with
unusual anatomy or vascular anomalies preventing insertion of apheresis catheter will
not qualify.

- Patients must have previous test results indicating adequate pulmonary function
studies (PFT) > 50% of predicted on mechanical aspects (FEV1, forced vital
capacity(FVC), etc) and diffusion capacity (DLCO) > 50% of predicted.

Exclusion Criteria:

- Participants must not have received prior treatment for their disease. Prior use of
bisphosphonates is permitted.

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 2 years.

- May not have history of poorly-controlled hypertension, diabetes mellitus, or any
other serious medical illness or psychiatric illness that could potentially interfere
with the completion of treatment according to this protocol or could be considered to
be an exclusion criterion deemed by the PI.

- Pregnant or nursing women may not participate. Women of childbearing potential must
have a negative pregnancy test documented within 10 to 14 days of enrollment.
Women/men of reproductive potential may not participate unless they have either
agreed to practice true abstinence, when this is in line with the preferred and usual
lifestyle of the participant. (Periodic abstinence [eg,calendar, ovulation,
symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of
contraception.) OR begin TWO reliable methods of birth control: 1 highly effective
method and 1 additional effective method AT THE SAME TIME, at least 28 days before
starting study treatment through 30 days after the last dose of study treatment.

- Serologic evaluation will be used to assess exposure to syphilis, West Nile Virus,
Chagas, cytomegalovirus (CMV), Immunoglobulin G (IgG), hepatitis B, and C, HIV I and
II, and human t cell lymphoma virus (HTLV) I/II. Participants may not be hepatitis
B or C (+) unless positive due to previous vaccination or positive but has received
therapy and is negative for hepatitis B or C by rapid test polymerase chain reaction
(RT-PCR). An HIV-I/II(+) and HTLV-1/II (+) participant will be rejected on medical
grounds. Participants serologically positive for syphilis, West Nile Virus, Chagas,
CMV, are only excluded if they are being treated for active infection.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Increase in ENK (Expanded Natural Killer Cells) cells after participants receive treatment

Outcome Description:

To determine the significance in expansion of auto-ENK cells defined as a >4 fold increase in absolute CD3-CD56+ NK cell count/blood 7 days after infusion over the pre-study baseline level and the safety of the ENK cell therapy in research participants with high-risk asymptomatic multiple myeloma defined as gene expression profile 70 gene score

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Frits Van Rhee, M.D., Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Food and Drug Administration

Study ID:

2013-05

NCT ID:

NCT01884688

Start Date:

April 2013

Completion Date:

February 2015

Related Keywords:

  • Asymptomatic Multiple Myeloma
  • Asymptomatic Multiple Myeloma
  • Auto-ENK Cell Therapy
  • Natural Killer Cells
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical ScienceLittle Rock, Arkansas  72205