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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mayo Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01646762
First received: June 19, 2012
Last updated: September 12, 2014
Last verified: September 2014

June 19, 2012
September 12, 2014
November 2012
February 2015   (final data collection date for primary outcome measure)
Proportion of patients who have a confirmed partial response or better [ 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, 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.
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.
Complete list of historical versions of study NCT01646762 on ClinicalTrials.gov Archive Site
  • Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • 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 ]
Not Provided
Not Provided
 
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma
Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Refractory Multiple Myeloma
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
    Given IV
    Other Names:
    • ABI-007
    • nab paclitaxel
    • nab-paclitaxel
    • nanoparticle albumin-bound paclitaxel
  • Other: laboratory biomarker analysis
    Correlative studies
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.
Interventions:
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01646762
MC1182, NCI-2012-00879, 11-007291, MC1182, P30CA015083
Yes
Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Rafael Fonseca Mayo Clinic in Arizona
Mayo Clinic
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP