Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)

Status: Recruiting
Phase: Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01782963 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-498

 

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.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital/ North Shore Cancer Center

Overall PI:
Jacob Laubach, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Noopur Raje, MD, Massachusetts General Hospital
David Avigan, MD, Beth Israel Deaconess Medical Center
Andrew Yee, MD, Massachusetts General Hospital

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Deborah Doss, 617-632-5672, ddoss@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility 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
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