Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma
I. To evaluate the efficacy (overall response rate) of single agent nab-paclitaxel
(Abraxane®) in patients with relapsed or refractory multiple myeloma.
I. To evaluate the adverse events associated with use of single agent nab-paclitaxel
(Abraxane) in patients with relapsed or refractory multiple myeloma.
II. To evaluate overall survival, time to progression, and duration of response among
patients with relapsed or refractory multiple myeloma undergoing treatment with single agent
Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV)
over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 12 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for up to 3
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate of single agent nabpaclitaxel (Abraxane®) in patients with relapsed or refractory multiple myeloma out to 3 years.
A confirmed partial response or better is defined to be a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) noted as the objective status on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the approach of Duffy and Santner.
Up to 3 years
Mayo Clinic in Arizona
United States: Food and Drug Administration
|Mayo Clinic in Arizona||Scottsdale, Arizona 85259-5404|