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A Phase IIA Open-Label, Randomized, Pharmacokinetic Comparative, Cross-Over Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation


Phase 2
18 Years
70 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase IIA Open-Label, Randomized, Pharmacokinetic Comparative, Cross-Over Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation


This study will be a multicenter, open-label, randomized, comparative, cross-over study of
high-dose Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection
conducted in 24 patients who have symptomatic MM and qualify for ASCT.

During the Study Period, patients will be randomized to receive 100mg/m2 of either Melphalan
HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection on Day -3 and the
alternate drug product on Day -2. Blood samples for pharmacokinetic (PK) evaluation will be
withdrawn through an indwelling i.v. cannula each day of melphalan dosing (Day -3 and Day
-2).

Following one day of rest after the myeloablative conditioning (Day -1), patients will
receive an autologous graft.


Inclusion Criteria:



- Patients with symptomatic MM requiring treatment at diagnosis or anytime thereafter.

- Patients with MM who qualify for ASCT therapy who have received appropriate primary
induction therapy for transplantation.

- Adult patients (≥ 18 years old) who are 70 years of age or younger at time of
transplant; patients greater than 70 years of age may qualify on a case-by-case basis
if the patient meets local institutional criteria to receive a total melphalan dose
of 200 mg/m2 as a conditioning regimen and if approved by the Medical Monitor.

- Patients with an adequate autologous graft which is defined as an unmanipulated,
cryopreserved, peripheral blood stem cell graft containing at least 2 × 106 CD34+
cells/kg based upon patient weight.

- Patients with adequate organ function as measured by:

- Cardiac: Left ventricular ejection fraction at rest >40% (documented within
12 weeks prior to Day -3).

- Hepatic: Bilirubin <2 × the upper limit of normal (ULN) and ALT/AST <3 × ULN.

- Renal: Creatinine clearance >40 mL/minutes (measured or calculated/estimated).

- Pulmonary: DLCO, FEV1, FVC >50% of predicted value (corrected for Hgb) or O2
saturation > 92% on room air (documented within 12 weeks prior to Day -3)

Exclusion Criteria:

- Patients who have never advanced beyond Stage 1 MM since diagnosis.

- Patients who have previously received more than one autologous stem cell transplant.

- Patients with plasma cell leukemia.

- Patients with MM and systemic AL amyloidosis.

- ECOG performance status ≥2.

- Patients with uncontrolled hypertension.

- Patients with an active bacterial, viral, or fungal infection.

- Patients with prior malignancies except resected basal cell carcinoma or treated
cervical carcinoma in situ. Cancer treated with curative intent >5 years previously
will be allowed. Cancer treated with curative intent <5 years previously will not be
allowed unless approved by the medical monitor.

- Female patients who are pregnant (positive ß-HCG) or breastfeeding.

- Female patients of childbearing potential who are unwilling to use adequate
contraceptive techniques during and for 1 month following study treatment with
Melphalan HCl for Injection (Propylene Glycol-Free).

- Patients seropositive for HIV.

- Patients who are unwilling to provide informed consent.

- Patients receiving other concurrent anticancer therapy (including chemotherapy,
radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids)
within 21 days prior to the ASCT, or planning to receive any of these treatments
prior to study discharge.

- Patients concurrently participating in any other clinical study.

- Patients who are hypersensitive or intolerant to any component of the study drug
formulation.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) versus Alkeran for Injection in MM patients undergoing ASCT.

Outcome Time Frame:

0,10,20,30,60,90,120,180,240,360,480 minutes after completion of each infusion

Safety Issue:

No

Principal Investigator

Omar Aljitawi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Food and Drug Administration

Study ID:

CDX-353-001

NCT ID:

NCT00925782

Start Date:

January 2010

Completion Date:

July 2011

Related Keywords:

  • Multiple Myeloma
  • autologous stem cell transplantation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Kansas Medical Center/University of Kansas Cancer Center and Medical PavillionKansas City, Kansas  66160