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

NCT01646762 | Terminated Phase 2 Results DMC

• 4 other identifiers: MC1182NCI-2012-0087911-007291P30CA015083
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Have a Confirmed Partial Response or Better

  A confirmed partial response or better will be considered synonymous with "success" and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + \<5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) noted as the objective status on two consecutive evaluations. The percentage of successes (confirmed PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. Confirmed PR or better will be evaluated using all cycles of treatment.

  Up to 3 years

Secondary Outcomes (5)

• Survival Time

  Time from registration to death due to any cause, assessed up to 3 years

• Progression Free Survival at 3 Months

  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 Partial Response or Better

  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 Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

  Up to 3 years

• Overall Response Rate

  Up to 3 years

Study Arms (1)

Treatment (chemotherapy)

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.

Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Other: Laboratory Biomarker Analysis

Interventions

Paclitaxel Albumin-Stabilized Nanoparticle Formulation DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane

Treatment (chemotherapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Taxes; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Rafael Fonseca
• Organization: Mayo Clinic

fonseca.rafael@mayo.edu

480-301-4280

Study Officials

• Rafael Fonseca

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: July 20, 2012
• Study Start: November 5, 2012
• Primary Completion: January 15, 2015
• Study Completion: October 27, 2015
• Last Updated: October 16, 2017
• Results First Posted: September 1, 2017

Record last verified: 2016-12

Locations

US (1)