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Multi-Center,Open-Label,Randomized,Phase 1B Study Evaluating Safety & Tolerability of Intravenous rhMBL in Pts With Multiple Myeloma Receiving Melphalan-Based High-Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplant


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

Thank you

Trial Information

Multi-Center,Open-Label,Randomized,Phase 1B Study Evaluating Safety & Tolerability of Intravenous rhMBL in Pts With Multiple Myeloma Receiving Melphalan-Based High-Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplant


MBL deficient patients will be randomized in a ratio of 2:2:1 to receive up to 4 weekly i.v.
infusions of rhMBL at a dose of 0.5 mg/kg or 1.0 mg/kg, or standard anti-infectious
prophylactic therapy alone. A total of 20 patients will be treated in each of the rhMBL
arms, and 10 patients will receive best standard supportive prophylactic therapy but not
rhMBL. All patients are to receive anti-infectious prophylactic supportive therapy as per
institutional standards.


Major

Inclusion Criteria:

Patients must meet all of the following criteria to be eligible
for enrollment into the study:

- Capable of understanding the protocol requirements and risks and providing written
informed consent.

- Histologically or cytologically confirmed diagnosis of multiple myeloma.

- Mannose-binding lectin level <300 ng/mL.

- Age ≥18 years old.

- Score of 0 to 2 on the Zubrod performance status scale.

- Patient is scheduled to receive melphalan-based high-dose chemotherapy and autologous
HSCT for the treatment of multiple myeloma.

Exclusion Criteria:

- Concurrent serious medical illness that could potentially interfere with protocol
compliance.

- Concurrent or previous malignancy associated with a poor prognosis.

- Known chronic infectious disease, such as acquired immunodeficiency syndrome (AIDS)
or hepatitis (for hepatitis and human immunodeficiency virus [HIV] will not be
performed).

- Positive screening pregnancy test or is breast-feeding.

- Female or male patient of reproductive capacity unwilling to use methods appropriate
to prevent pregnancy during the course of this protocol.

- Known or clinically suspected active brain metastases.

- Current participation in another clinical study with an investigational agent and/or
use of an investigational drug.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability of rhMBL

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Elias Anaissie, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Food and Drug Administration

Study ID:

EZN-2232-01

NCT ID:

NCT00388999

Start Date:

September 2006

Completion Date:

May 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Stem Cell Transplant
  • rhMBL
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205