Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma
|Refractory Plasma Cell Myeloma||Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation Other: Laboratory Biomarker Analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma|
- Proportion of patients who have a confirmed partial response or better [ Time Frame: Up to 3 years ]A confirmed partial response or better is defined to be a stringent complete response, complete response, very good partial response, or partial response (PR) noted as the objective status on two consecutive evaluations. The proportion of successes (confirmed PR or better) 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.
- Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 3 years ]The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Time to disease progression [ Time Frame: Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years ]The distribution of time to progression will be estimated using the method of Kaplan-Meier. Several estimates of time to progression, such as 3 and 6 month progression-free rates will be provided. Furthermore, analyses will include censoring patients for progression at their first disease assessment after completion of treatment, in order to provide a more conservative estimate of time to progression by removing any bias present from the patient's receiving subsequent and off-study treatment(s).
- Duration of response of all evaluable patients who have achieved a confirmed partial response or better [ Time Frame: Date at which the patient's earliest best objective status is first noted to be at least a partial response or better to the earliest date progression is documented, assessed up to 3 years ]The distribution of duration of response will be estimated using the method of Kaplan-Meier.
- Incidence of adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 years ]The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Other Names:Other: Laboratory Biomarker Analysis
I. To evaluate the efficacy (overall response rate) of single agent nab-paclitaxel (Abraxane) (paclitaxel albumin-stabilized nanoparticle formulation) 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 nab-paclitaxel (Abraxane).
Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 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 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646762
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|Principal Investigator:||Rafael Fonseca||Mayo Clinic|