Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma

• Status: Completed
• Trial end date: 2014-09-03
• Target enrollment: 0
• Participant gender: All

Summary

This research study is evaluating an investigational combination of four drugs called Revlimid® (lenalidomide), Velcade® (bortezomib), Dexamethasone and Doxil® (RVDD) as a possible treatment for newly diagnosed multiple myeloma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Lenalidomide; Liposomal doxorubicin; Thalidomide

Criteria

Inclusion Criteria

• At least 18 years of age at the time of consent

• Measurable disease

• All necessary baseline studies completed

• LVEF (left ventricular ejection fraction) greater than or equal to 50 percent by MUGA (multigated acquisition scan) or ECHO (echocardiogram)

• Must be able to adhere to study visit schedule

Exclusion

• Greater than or equal to grade 2 peripheral neuropathy on clinical examination within 14 days of enrollment

• Renal insufficiency

• Evidence of mucosal or internal bleeding and/ or platelet refractory.

• Absolute neutrophil count less than 1000 cells/mm^2 within 14 days of enrollment.

• Acceptable labs

• Concomitant medications that include corticosteroids

• Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias

• Clinically relevant active infection or serious medical condition that places the subject at unacceptable risk

• Any condition, including laboratory values that places the subject at an unacceptable risk

• Another malignancy within 3 years of enrollment, with the exception of the complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy

• Hypersensitivity to bortezomib, boron, or mannitol or any of the components of DOXIL

• Female subject that is pregnant or breastfeeding.

• Can not have received any other investigational drugs within 14 days of enrollment

• Serious medical or psychiatric illness

• Uncontrolled diabetes mellitus

• Hypersensitivity to acyclovir or similar antiviral drug

• POEMS (plasma cell dyscrasia with polyneuropathy)

• Known HIV

• Known hepatitis B or C

• Known intolerance to steroid therapy

• Known hypersensitivity to required prophylactic mediations