Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Fibrinolytic Agents

Anticoagulants

Antipyretics

Antirheumatic Agents

Analgesics

Platelet Aggregation Inhibitors

Bone Density Conservation Agents

Antibodies

Dexamethasone

Anti-Bacterial Agents

Bendamustine Hydrochloride

Heparin

Aspirin

Calcium

Lenalidomide

Dexamethasone acetate

Antibiotics, Antitubercular

Warfarin

Immunoglobulins

Omeprazole

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Acyclovir

Calcium, Dietary

Immunoglobulins, Intravenous

Fluconazole

Trimethoprim, Sulfamethoxazole Drug Combination

Histamine H2 Antagonists

Proton Pump Inhibitors

Ranitidine

Ranitidine bismuth citrate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Treatment with Bendamustine in combination with Lenalidomide and Dexamethasone will be administered on an outpatient basis. Each treatment cycle will be 28 days dosed according to the Dose Escalation Schema.

Bendamustine is given intravenously (into a vein or IV infusion) on days 1 and 2 of each cycle. Each bendamustine infusion will take 60 minutes

Bendamustine

Lenalidomide is taken orally (by mouth) in the morning on days 1 through 21 of each cycle.

Dexamethasone is taken orally (by mouth) on days 1, 8, 15, and 22 of each cycle.

All patients will receive enteric coated aspirin, 325 mg, QD while on study. If patient is unable to tolerate aspirin, patient should receive other types of anti-coagulation like Coumadin or low molecular weight heparin.

All patients will receive prophylaxis with either an H-2 blocker or proton pump inhibitor (PPI) while on study medications. Suggested medications included ranitidine 150 mg PC BID or omeprazole 20 mg PO QD or equivalent.

Prophylaxis

PCP antibiotic prophylaxis with a Bactrim will be recommended. In case of history of zoster or fungal infection a prophylaxis with Acyclovir or Diflucan should be also considered.

Antibiotic

Vital signs (heart rate, breathing rate, blood pressure, and temperature) will be measured, and Blood tests to check CBC, Calcium, Electrolytes, serum, creatinine, and BUN. This follow up will take place at the Hillman Cancer Center, or whichever cancer center in which the subject is treated.

Biweekly Follow Up

At the beginning of each treatment cycle subjects will undergo a Physical exam, a Performance status check, Recording of any new symptoms or side effects and any new medications, Blood tests (including blood chemistry, organ function and indicators of disease), Urine test, and pregnancy test (if applicable).

Cyclical Follow Up

Every other cycle subjects' disease will be restaged. This will be accomplished by their treatment physician. Re-staging procedures includes a regular office visit, x-ray, and a bone marrow biopsy. Subjects will spend approximately 4 hours at the Hillman Cancer Center or the UPMC Cancer Center location where they are being treated for this re-staging.

Restaging

After subjects stop receiving the study drugs, they will be followed every 3 months for the first two years, every 6 months for years 2-5, and annually thereafter. The following procedures, which are considered routine for their cancer care, will be done as part of this follow-up:

* Physical exam
* Performance status (check of ability to perform daily functions)
* Recording of any new symptoms and any new medications being taken
* Blood tests to check blood counts (numbers of red and white blood cells and platelets), blood chemistry (to check organ function), and indicators of disease (immunoglobulins)
* Urine test (24hr urine)
* Women who are able to have children will have a pregnancy test (4 weeks after their last dose of lenalidomide).
* A check of the status of disease (includes bone marrow biopsy, skeletal survey, and blood and urine tests). Bone marrow biopsy will be done at the end of treatment, if subjects have a complete response, and their disease gets worse.

Post-Treatment Follow Up

Robert L Redner, M.D.

The purpose of this study is to see if the combination of bendamustine, lenalidomide and dexamethasone will help people with multiple myeloma that has returned after standard treatment or has been resistant to other treatments.

Bendamustine in Combination With Lenalidomide and Dexamethasone in Refractory or Relapsed Multiple Myeloma

Phase I Study of Bendamustine in Combination With Lenalidomide (CC-5013) and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

Cephalon

Robert Redner, MD

Professor, Division of Hematology/Oncology, Department of Medicine

Spots Global Cancer Trial Database for biweekly follow up