Overview

This trial is active, not recruiting.

Condition refractory plasma cell myeloma
Treatments paclitaxel albumin-stabilized nanoparticle formulation, laboratory biomarker analysis
Phase phase 2
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date November 2012
End date September 2016
Trial size 13 participants
Trial identifier NCT01646762, 11-007291, MC1182, NCI-2012-00879, P30CA015083

Summary

This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with multiple myeloma that has returned or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
paclitaxel albumin-stabilized nanoparticle formulation ABI 007
Given IV
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Proportion of patients who have a confirmed partial response or better
time frame: Up to 3 years

Secondary Outcomes

Measure
Survival time
time frame: Time from registration to death due to any cause, assessed up to 3 years
Time to disease progression
time frame: Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Absolute neutrophil count >= 500/mm^3 - Platelet count >= 25000/mm^3 - Hemoglobin >= 6 g/dL - Total bilirubin =< 2.5 X institutional upper limit of normal (ULN) - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 5 X ULN - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 X ULN - Creatinine =< 3 mg/dL - Patients with relapsed or refractory myeloma who have had >= 3 lines of prior therapy - Measurable disease of multiple myeloma as defined by at least ONE of the following: - Serum monoclonal protein >= 1.0 g/dL - > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis - Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio - Ability to understand and the willingness to sign a written informed consent document - Negative (serum) pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; NOTE: Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately - Willing to return to enrolling institution (Mayo Clinic in Arizona) for follow-up and all study treatments Exclusion Criteria: - Myelosuppressive therapy for myeloma =< 14 days prior to registration or those who have not recovered from acute reversible adverse events due to agents administered > 21 days earlier - Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are allowed while on protocol treatment; patients may be receiving stable doses of corticosteroids with a maximum dose of 10 mg of prednisone per day if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica or adrenal insufficiency, or asthma - Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment (i.e. other investigational therapy, anti-neoplastic therapy, etc.) for their cancer - Any of the following: - Pregnant women or women of reproductive ability who are unwilling to use effective contraception - Nursing women - NOTE: breastfeeding should be discontinued if the mother is treated with nab-paclitaxel (Abraxane®) - Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment - Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease - Patients with a >= grade 2 peripheral neuropathy

Additional Information

Official title Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma
Principal investigator Rafael Fonseca
Description PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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). OUTLINE: 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.
Location data was received from the National Cancer Institute and was last updated in June 2016.