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

This study is currently recruiting participants.
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Rafael Fonseca, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01646762
First received: June 19, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This research study is being done 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. In addition, the study intends to evaluate overall survival, time to progression, and duration of response among patients with relapsed or refractory multiple myeloma as well as evaluate the adverse events associated with use of single agent nab-paclitaxel (Abraxane®) in patients with relapsed or refractory multiple myeloma


Condition Intervention Phase
Refractory Multiple Myeloma
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Overall response rate of single agent nabpaclitaxel (Abraxane®) in patients with relapsed or refractory multiple myeloma out to 3 years. [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Survival time of all evaluable patients who have achieved a confirmed partial response or better out to 3 years [ Time Frame: Time from registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
  • Time to disease progression of all evaluable patients who have achieved a confirmed partial response or better out to 3 years [ Time Frame: Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years ] [ Designated as safety issue: No ]
  • Adverse event rate(s) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Other Names:
  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the efficacy (overall response rate) of single agent nab-paclitaxel (Abraxane®) 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 glutamic 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
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) >= 2 (2, 3 or 4)
  • 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 considered to be supportive care rather than therapy, and are thus 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: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nab-paclitaxel (Abraxane®), 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646762

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Mayo Clinic Clinical Trials Office    507-538-7623      
Principal Investigator: Rafael Fonseca, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Rafael Fonseca, M.D. Mayo Clinic in Arizona
  More Information

No publications provided

Responsible Party: Rafael Fonseca, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01646762     History of Changes
Other Study ID Numbers: MC1182, NCI-2012-00879
Study First Received: June 19, 2012
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014