Overview

Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)

Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs. The purpose is to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied. It also means that research doctors are trying to find out more about it. Examples of what they want to learn about are the safest dose to use, the side effects it may cause, and if the combination of drugs works for treating different types of cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts General Hospital
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
Criteria
Inclusion Criteria:

- Documented symptomatic myeloma, with organ damage related to myeloma

- Myeloma that is measurable either by serum or urine evaluation of the monoclonal
component or by assay of serum free light chains

- Must commit to complete abstinence from heterosexual contact or begin two acceptable
method of birth control, one highly effective method and one additional effective
(barrier) method

Exclusion Criteria:

- Eligible for autologous stem cell transplantation

- HIV positive on combination antiretroviral therapy

- Pregnant or breastfeeding

- Treated with any prior systemic therapy

- Primary amyloidosis or myeloma complicated by amyloidosis

- Receiving other investigational agents within 14 days of the start of this trial or
during this trial

- Known brain metastases

- Poor tolerability or known allergy to any of the study drugs or similar compounds

- Intercurrent illness

- Previous history of another malignant condition except for basal cell carcinoma or
stage I cervical cancer

- Inability to comply with an anti-thrombotic treatment regimen

- Peripheral neuropathy greater than or equal to grade 2