Know Cancer

forgot password

A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide (DVD-R) for Patients With Relapsed/Refractory Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Relapsed/Refractory Multiple Myeloma

Thank you

Trial Information

A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide (DVD-R) for Patients With Relapsed/Refractory Multiple Myeloma

Inclusion Criteria:

- Each patient must meet all of the following inclusion criteria to be enrolled in the

1. Has a diagnosis of multiple myeloma based on standard criteria (Durie 1986)

2. Currently has multiple myeloma with measurable disease (serum m protein >
1.0g/dl and/or 24 hr urine m protein > 200mg/24 hr)

3. Currently has progressive multiple myeloma that has relapsed or is refractory

4. Voluntarily signed an informed consent

5. Age 18 years

6. Able to adhere to the study visit schedule and other protocol requirements

7. ECOG performance < 2

8. Life-expectancy > 3 months

9. Laboratory test results within these ranges:

- ANC 1.5 x 109/L; if the bone marrow is extensively infiltrated (> 70%
plasma cells) then 1.0 x 109/L

- Platelet count 75 x 109/L; if the bone marrow is extensively infiltrated (>
70% plasma cells) then 50 x 109/L

- Hg > 8 g/dL

- Calculated or measured creatinine clearance > 30 mL/minute.

- Total bilirubin 2.0 x upper limit of normal (ULN)

- AST (SGOT) and ALT (SGPT) 3 x ULN or 5 x ULN if hepatic metastases are

- Serum potassium within the normal range

10. Disease free of prior malignancies for 5 years with exception of currently
treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ"
of the cervix or breast

11. Registered into the mandatory RevAssist® program, willing and able to comply
with the requirements of RevAssist®.

12. Females of childbearing potential must have a negative serum or urine pregnancy
test and must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control.

13. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation
(patients intolerant to ASA may use warfarin or low molecular weight heparin)

Exclusion Criteria:

- Patients meeting any of the following exclusion criteria are not to be enrolled in
the study:

1. Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy,
monoclonal protein and skin changes syndrome

2. Plasma cell leukemia

3. Non-measurable multiple myeloma

4. Grade 2 peripheral neuropathy within 14 days before enrollment

5. Impaired cardiac function or clinically significant cardiac diseases, including
any one of the following:

- Myocardial infarction within 6 months prior to enrollment

- New York Heart Association (NYHA) Class II or greater heart failure

- Uncontrolled angina

- Clinically significant pericardial disease

- Severe uncontrolled ventricular arrhythmias

- Echocardiogram or MUGA evidence of LVEF below institutional normal within
28 days prior to enrollment

- Electrocardiographic evidence of acute ischemia or active conduction system
abnormalities. Prior to study entry, any ECG abnormality at Screening has
to be documented by the investigator as not medically relevant.

6. Severe hypercalcemia, i.e., serum calcium 12 mg/dL (3.0 mmol/L) corrected for

7. Any serious medical condition, laboratory abnormality, or psychiatric illness
that would prevent the subject from signing the informed consent form

8. Any condition, including the presence of laboratory abnormalities, which places
the subject at unacceptable risk if he/she were to participate in the study or
confounds the ability to interpret data from the study

9. Undergone major surgery within 28 days prior enrollment or has not recovered
from side effects of such therapy (Kyphoplasty is not considered to be a major
surgery; however, the investigator is to discuss enrollment of a patient with a
recent history of kyphoplasty with the medical monitor).

10. Pregnant or breast feeding females. (Lactating females must agree not to breast
feed while taking lenalidomide)

11. Received the following prior therapy:

- Chemotherapy within 3 weeks of enrollment (6 wks for nitrosoureas)

- Corticosteroids (>10 mg/day prednisone or equivalent) within 3 weeks of

- Immunotherapy or antibody therapy as well as thalidomide, lenalidomide,
arsenic trioxide or bortezomib within 21 days before enrollment

- Radiation therapy within 28 days before enrollment, receipt of localized
radiation therapy does not preclude enrollment

- Use of any other experimental drug or therapy within 28 days of enrollment

12. Known hypersensitivity to compounds of similar chemical or biological
composition to thalidomide, doxorubicin, bortezomib, boron or mannitol.

13. The development of erythema nodosum if characterized by a desquamating rash
while taking thalidomide or similar drugs

14. Concurrent use of other anti-cancer agents or treatments

15. Known positivity for human immunodeficiency virus (HIV) or hepatitis B or C;
baseline testing for HIV and hepatitis B or C is not required

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

IMWG Response Criteria

Outcome Description:

The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have CR, VGPR, PR, or MR, then assessment of disease response is to be performed 4 weeks later to confirm the response.

Outcome Time Frame:

up to 32 weeks

Safety Issue:


Principal Investigator

James R. Berenson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James R. Berenson, MD, Inc.


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

February 2012

Related Keywords:

  • Relapsed/Refractory Multiple Myeloma
  • multiple myeloma
  • refractory
  • relapsed
  • bortezomib
  • doxil
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Comprehensive Blood and Cancer Center Bakersfield, California  93309
Broome Oncology Johnson City, New York  13790
Loma Linda University Loma Linda, California  92354
James R. Berenson, M.D., Inc. West Hollywood, California  
Hematology-Oncology Medical Group of Fresno, Inc. Fresno, California  93720
Santa Barbara Hematology Oncology Santa Barbara, California  93105
Watson Clinic, LLP, Center for Care and Research Lakeland, Florida  33805
Bassett Cancer Institute Cooperstown, New York  13326