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Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

- Participants will begin taking the study medication in the clinic on Cycle 1 day 1.
Each treatment cycle lasts three weeks. They will take the lenalidomide (capsules)
every day for the first two weeks only (days 1-14). They will take dexamethasone
(tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and will come to the outpatient treatment
center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle
is a rest period and the participant will not be taking any study medication.

- Certain tests and procedures will be performed throughout each treatment cycle at
definitive time periods. These tests include: medical history update,
physical/neurological examination, skeletal survey (x-rays or scan), blood samples,
urine samples, optional bone marrow aspiration/tissue biopsy, 12-lead ECG, and MRI/CT
(if needed).

- It is expected that participants will complete at least 8 cycles of the study, which
adds up to 168 days. If the participant completes the first 8 cycles, 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:

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

- Relapsed or relapsed and refractory disease after receiving between 1 and 3 prior

- Negative serum or urine pregnancy test

- Age 18 years or older

- Karnofsky performance status of 60 or greater

Exclusion Criteria:

- Grade 2 or greater peripheral neuropathy 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 or has NYHA Class III or IV
heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
electrocardiographic evidence of acute ischemia or active conduction system

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

- Prior malignancy (within last 3 years) except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical or breast cancer, in situ prostate cancer

- Pregnant or breast-feeding

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

- 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

- Subjects with primary refractory disease, defined as progression during initial

Type of Study:


Study Design:

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

Outcome Measure:

Evaluate time to progression following bortezomib, lenalidomide and dexamethasone combination therapy treatment in patients with relapsed or refractory multiple myeloma.

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:

December 2014

Related Keywords:

  • Multiple Myeloma
  • relapsed multiple myeloma
  • refractory multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617