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An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma


Inclusion Criteria:



- Relapsed or Refractory Multiple Myeloma

- ≥ 18 years old

- Able to provide consent for participation

- ECOG status 0-2

Lab values:

- ANC ≥ 1,000/µL

- WBC count ≥ 2.0/µL

- Hemoglobin ≥ 8.0 g/dL

- Platelet count ≥ 50,000/µL

- AST and ALT ≤ 2 x ULN

- Total Bilirubin ≤ 2 x ULN

- Creatinine ≤ 2.0 mg/dL

and

- Not pregnant or lactating

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of complete response, partial response and stable disease (clinical benefit rate)

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0215

NCT ID:

NCT00096837

Start Date:

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Robert H. Lurie Comprehensive Cancer CenterChicago, Illinois  60611