Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed multiple myeloma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geron Corporation
• Treatments: Imetelstat; Motesanib diphosphate; Niacinamide

Criteria

Inclusion Criteria:

• Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)

• Relapsed or refractory disease

• At least two prior treatment regimens

• ECOG performance status 0-2

• Adequate hepatic/renal function and platelet count

• If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50%

Exclusion Criteria:

• Prior allogeneic bone marrow transplant, including syngeneic transplant

• Known intracranial disease or epidural disease

• Prior malignancy (within the last 3 years)

• Clinically significant cardiovascular disease or condition

• Active or chronically recurrent bleeding (eg, active peptic ulcer disease

• Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN

• Clinically relevant active infection

• Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease

• Symptomatic hyperviscosity syndrome

• Any other cancer therapy within 3 weeks prior to study, except for mitomycin C, nitrosoureas, or high-dose chemotherapy with stem cell support within 6 weeks prior to study

• Investigational therapy within 4 weeks prior to study

• Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of IV access devices

• Radiation therapy within 4 weeks prior to study

• Major surgery within 4 weeks prior to study

• Active autoimmune disease requiring immunosuppressive therapy

• Known positive serology for HIV