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An Open-Label Phase I/II Study of the Safety and Efficacy of Bortezomib, Lenalidomide and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

An Open-Label Phase I/II Study of the Safety and Efficacy of Bortezomib, Lenalidomide and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

- The safe dose of dexamethasone is already known. The dose of bortezomib and
lenalidomide will be increased during the study until the best and safest amount (or
dose) is identified. The participant's dose of the study drugs will depend on when
they enter the study.

- In this study each cycle will be 21 days and participants will begin the study
medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily
for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1,
2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient
treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study
medication will be given.

- During the course of the study treatment, tests and procedures will be performed at
designated time periods. This includes; medical history updates, physical/neurological
examinations, skeletal survey (x-rays or scan), blood samples, optional bone marrow
aspiration/tissue biopsy, urine samples, 12-lead ECG, and MRI/CT scan (if needed).

- It is expected that study participants will receive study treatment for 8 cycles (168
days). If the participant completes the first 8 cycles of the study, has stable or
responding disease and has not experienced bad side effects, they will be allowed to
continue treatment on a maintenance schedule, detailed in the protocol, at the study
doctor's discretion.

Inclusion Criteria:

- Diagnosed with multiple myeloma based on standard diagnostic criteria or by the new
International Myeloma Foundation 2003 Diagnostic Criteria

- Must not have been previously treated with any prior systemic therapy for the
treatment of multiple myeloma

- Negative serum or urine pregnancy test

- Age 18 years or older

- Karnofsky performance status of greater or equal to 60

Exclusion Criteria:

- Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14
days before enrollment

- Renal insufficiency (serum creatinine >2.5 mg/dL)

- Evidence of mucosal or internal bleeding and/or platelet refractory

- ANC < 1000 cells/mm3

- Hemoglobin < 8.0 g/dL

- AST or ALT greater than or equal to 2 x ULN

- Concomitant therapy medications that include corticosteroids

- Myocardial infarction within 6 months prior to enrollment according to NYHY Class III
or IV heart failure, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction
system abnormalities

- Clinically relevant active infection or serious co-morbid medical conditions

- Prior malignancy except adequately treated basal cell or squamous cell skin cancer,
in situ cervical, breast or prostate cancer

- Pregnant or breast-feeding

- Serious medical or psychiatric illness likely to interfere with participation in

- Uncontrolled diabetes mellitus

- Hypersensitivity to acyclovir or similar anti-viral drug

- POEMS syndrome

- Known HIV infection

- Known active hepatitis B or C viral infection

- Known intolerance to steroid therapy

Type of Study:


Study Design:

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

Outcome Measure:

Determine the maximum tolerated dose of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Paul Richardson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

February 2016

Related Keywords:

  • Multiple Myeloma
  • newly diagnosed multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617