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A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for Patients With Newly Diagnosed Multiple Myeloma (MM)

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for Patients With Newly Diagnosed Multiple Myeloma (MM)



- To determine the response rate (i.e., complete response, very good partial response ,
partial response, and minimal response) in patients with newly diagnosed multiple
myeloma treated with pegylated liposomal doxorubicin hydrochloride, bortezomib, and


- To assess the safety and tolerability of this regimen in these patients.

- To determine the time to disease progression, time to response, duration of response,
progression-free survival, and overall survival of patients treated with this regimen.

OUTLINE: Patients receive pegylated liposomal doxorubicin hydrochloride IV over 30-90
minutes, dexamethasone IV, and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats
every 28 days for up to 8 courses in the absence of disease progression or unacceptable

Blood and urine samples are collected at baseline and periodically during study for
M-protein analysis by electrophoresis and immunofixation.

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


- Diagnosis of multiple myeloma based on the following criteria:

- Major criteria

- Plasmacytomas on tissue biopsy (1)

- Bone marrow plasmacytosis (> 30% plasma cells) (2)

- Monoclonal immunoglobulin spike on serum electrophoresis IgG > 3.5 g/dL or
IgA > 2.0 g/dL and kappa or lambda light chain excretion > 1 g/day on
24-hour urine protein electrophoresis (3)

- Minor criteria

- Bone marrow plasmacytosis (10% to 30% plasma cells) (a)

- Monoclonal immunoglobulin present but of lesser magnitude than given under
major criteria (b)

- Lytic bone lesions (c)

- Normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL (d)

- Meets 1 of the following sets of diagnostic criteria:

- Any two of the major criteria

- Major criteria 1 and minor criteria b, c, and d

- Major criteria 3 and minor criteria a or c

- Minor criteria a, b, c, OR a, b, d

- Measurable disease, defined as a monoclonal immunoglobulin spike on serum
electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/24
hours, or evidence of lytic bone disease

- No nonmeasurable disease (i.e., non-secretory or oligosecretory multiple

- Symptomatic, newly diagnosed, and previously untreated multiple myeloma

- No POEMS syndrome (i.e., plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein [M-protein], and skin changes)

- No plasma cell leukemia


- Karnofsky performance status 60-100%

- Life expectancy > 3 months

- ANC ≥ 1,500/mm^³ (≥ 1,000/mm^³ if bone marrow is extensively infiltrated)

- Platelet count ≥ 75,000/mm^³ (≥ 50,000/mm^³ if bone marrow is extensively

- Hemoglobin ≥ 8.0 g/dL

- AST and ALT ≤ 3.0 times upper limit of normal (ULN)

- Serum bilirubin ≤ 2.0 times ULN

- Creatinine clearance ≥ 30 mL/min OR creatinine > 10 mL/min and < 30 mL/min for
patients with significant myelomatous involvement of the kidneys

- Serum potassium ≥ lower limit of normal (LLN)

- Serum sodium ≥ LLN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior malignancy within the past 5 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

- No peripheral neuropathy ≥ grade 2 within past 14 days

- No impaired cardiac function or clinically significant cardiac disease, including any
one of the following:

- Myocardial infarction within the past 6 months

- New York Heart Association class II-IV heart failure

- Uncontrolled angina

- Clinically significant pericardial disease

- Severe uncontrolled ventricular arrhythmias

- LVEF below normal by ECHO or MUGA scan

- ECG evidence of acute ischemia or active conduction system abnormalities

- Screening ECG abnormality must be documented by the investigator as not
medically relevant

- No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL [3.5 mmol/L])

- No poorly controlled hypertension, diabetes mellitus, or other serious medical or
psychiatric illness that could preclude study treatment

- No known HIV positivity or hepatitis B or C positivity

- Baseline testing for HIV and hepatitis B or C is not required

- No history of allergic reaction attributable to compounds of similar chemical or
biological composition to doxorubicin, bortezomib, boron, or mannitol


- See Disease Characteristics

- No prior or concurrent anti-myeloma therapy except steroids

- Prior prednisone for ≤ 4 days at a total of 400 mg (or an equivalent potency of
another steroid) allowed

- No concurrent corticosteroids (≥ 10 mg prednisone/day or equivalent) other than

- More than 4 weeks since prior major surgery and recovered

- Prior kyphoplasty with oncotherapeutic drugs allowed at the investigator's

- More than 4 weeks since prior immunotherapy, antibody therapy, or radiotherapy

- More than 14 days since other prior and no other concurrent investigational drugs

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response, very good partial response, partial response, and minimal response) as assessed by modified Bladé criteria at baseline, on day 1 of each course, and at end-of-study

Safety Issue:


Principal Investigator

James R. Berenson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

July 2008

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



New York Medical College Valhalla, New York  10595
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Sutter Cancer Center at Roseville Medical Center Roseville, California  95661
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara Santa Barbara, California  93105
Arizona Clinical Research Center, Incorporated Tucson, Arizona  85715
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Charleston Hematology Oncology Associates, PA Charleston, South Carolina  29403
San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido Escondido, California  92025
Oncology Care Medical Associates - San Gabriel Los Angeles, California  90057
Desert Cancer Care Rancho Mirage, California  92270
James R. Berenson MD, Incorporated West Hollywood, California  90069