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A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant

Phase 2
18 Years
Not Enrolling
Refractory Multiple Myeloma

Thank you

Trial Information

A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant


I. To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with
bortezomib, pegylated liposomal doxorubicin hydrochloride, dexamethasone, and


I. To evaluate response rates in patients treated with this regimen. II. To evaluate the
median time to progression in patients treated with this regimen.

III. To evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV on days 1, 4, 8, and 11; pegylated liposomal doxorubicin
hydrochloride IV over 1 hour on day 4; oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and
12; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to
12 courses in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples may be collected for future research. Patients
complete the FACT neurotoxicity questionnaire periodically.

After completion of study treatment, patients are followed up every 3 months for 3 years.

Inclusion Criteria:

- Diagnosis of multiple myeloma that was symptomatic at the time of initial diagnosis

- Must have met the following criteria at one point during the disease course:

- Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or
biopsy-proven plasmacytoma

- Symptomatic disease at initial diagnosis that prompted the initiation of therapy
as well as evidence of end-organ damage at the time of diagnosis, including at
least 1 of the following:

- Anemia

- Hypercalcemia

- Bone disease (lytic bone lesions or pathologic fracture)

- Renal dysfunction

- Disease relapsed < 12 months after autologous stem cell transplantation (SCT)

- No more than two lines of prior therapy for multiple myeloma, including the
autologous SCT (autologous SCT, preceding induction therapy, and any maintenance
therapy will be considered one line of therapy)

- No therapy for relapsed disease following SCT

- Measurable disease, as defined by the presence of ≥ 1 of the following:

- Serum M-spike ≥ 1 g/dL

- Urine M-spike ≥ 200 mg/24 hours

- Involved free light chain (FLC) ≥ 10 mg/dL (provided the serum FLC is abnormal)

- Plasma cells ≥ 30%

- ECOG performance status 0-2

- Hemoglobin > 8 g/dL

- Platelet count ≥ 75,000/mm^3 (without transfusion support)

- ANC ≥ 1,000/mm^3 (without use of growth factors)

- Creatinine < 2.5 mg/dL

- Direct bilirubin ≤ 1.5 mg/dL

- ALT and AST ≤ 2.5 times upper limit of normal

- LVEF normal by ECHO or MUGA scan

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active, uncontrolled seizure disorder

- No seizures within the past 6 months

- No concurrent uncontrolled illness that would limit study compliance, including the

- Uncontrolled hypertension

- Symptomatic congestive heart failure

- Unstable angina

- Uncontrolled cardiac arrhythmia

- Uncontrolled psychiatric illness or social situation

- Active uncontrolled infection

- No peripheral neuropathy ≥ grade 2 according to the CTEP active version of the NCI

- Prior malignancy allowed provided it was treated curatively and has not relapsed in 5

- Patients with basal cell skin cancer, in situ cervical cancer, or prostate
cancer not requiring therapy are eligible

- No known allergy to bortezomib or anthracyclines

- At least 14 days since prior palliative and/or localized radiotherapy

- No prior allogeneic SCT

- No prior doxorubicin hydrochloride exposure > 240 mg/m^2

Type of Study:


Study Design:

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

Outcome Measure:

One-year overall survival

Outcome Description:

Estimated using the method of Kaplan and Meier

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Shaji Kumar

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

Related Keywords:

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



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