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Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Refractory Multiple Myeloma

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Trial Information

Phase II Trial of Nab-paclitaxel (Abraxane®) in Patients With Relapsed or Refractory Multiple Myeloma


I. To evaluate the efficacy (overall response rate) of single agent nab-paclitaxel
(Abraxane®) in patients with relapsed or refractory multiple myeloma.


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®).


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

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]) =<

- Serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 X

- 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

- 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

*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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate of single agent nabpaclitaxel (Abraxane®) in patients with relapsed or refractory multiple myeloma out to 3 years.

Outcome Description:

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.

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Rafael Fonseca

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic in Arizona


United States: Food and Drug Administration

Study ID:




Start Date:

November 2012

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404