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Phase I Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation.


Phase 1
18 Years
70 Years
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

Phase I Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation.


Inclusion Criteria:



All patients age > =18 who have been diagnosed with Multiple Myeloma and are scheduled for
autologous peripheral blood hematopoietic stem cell transplant (AHSCT) will be screened
for eligibility.

Patients must fulfill all of the following inclusion criteria to be eligible for this
study:

1. Diagnosis of Multiple Myeloma

2. Age >=18 and no more than 70 years.

3. Able to understand and sign a consent form.

4. Can collect peripheral blood stem cells with a CD34+ cell dose of at least 5.0 x
106/kg. The CD34 molecule is a Cluster of Differentiation molecule present on
hematopoietic stem cells.

5. Conditioning regimen to be high dose Melphalan at a dose of 200mg/m2.

6. Karnofsky Performance Score (KPS) >60 or ECOG (Eastern Cooperative Oncology Group)
performance status <=2

7. Kidney function:Creatinine <2.0 mg/dl or creatinine clearance >50 ml/min

8. Heart function: Ejection fraction >45%

9. Liver function tests :Serum bilirubin, alanine aminotransferase (ALT), aspartate
aminotransferase (AST) less than 3 X upper limit of normal

10. Lung function tests: Forced Vital Capacity (FVC), Forced Expiratory Volume in One
Second (FEV1) or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >45%
predicted

Exclusion Criteria:

1. Age <18 years or > 70 years

2. Previous exposure to denileukin diftitox.

3. Patients with documented uncontrolled central nervous system (CNS) disease.

4. Previous AHSCT.

5. Significant organ dysfunction deemed to be inappropriate for autologous
transplantation.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess toxicities of giving two doses of Ontak at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion.

Outcome Description:

After drug infusion, participants will be closely monitored for at least 4 hours for side effects

Outcome Time Frame:

Up to 21 days post transplant

Safety Issue:

Yes

Principal Investigator

Zaid Al-Kadhimi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

WSU 2010-039

NCT ID:

NCT01251952

Start Date:

November 2010

Completion Date:

June 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201