A Study of Motexafin Gadolinium for the Treatment of Relapsed or Refractory Multiple Myeloma

Pharmacyclics

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Motexafin Gadolinium Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00096837

PCYC-0215

Details and patient eligibility

About

The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)