Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma

Stopped early · Phase 2

Conditions studied: Refractory Plasma Cell Myeloma

In brief

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.

Key facts

Study ID

NCT01646762

Run by

Mayo Clinic

People needed

13

Starts

2012-11-05

Expected to finish

2015-10-27

Last updated by the study team

2017-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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