Bendamustine in Combination With Lenalidomide and Dexamethasone in Refractory or Relapsed Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01042704|
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Drug: Bendamustine Drug: Lenalidomide Drug: Dexamethasone Drug: Aspirin Drug: Prophylaxis Drug: Antibiotic Other: Biweekly Follow Up Other: Cyclical Follow Up Other: Restaging Other: Post-Treatment Follow Up||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Bendamustine in Combination With Lenalidomide (CC-5013) and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||March 2015|
Experimental: Bendamustine, Lenalidomide and Dexamethasone
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
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.
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.
Other: Biweekly Follow Up
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.
Other: Cyclical 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).
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.
Other: Post-Treatment Follow Up
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:
- To establish the dose of each drug recommended for a future Phase II protocol with the combination [ Time Frame: 1 year ]
- To explore anti-tumor activity of the combination of Bendamustine plus Lenalidomide and dexamethasone [ Time Frame: 2.5 years ]
- Toxicity, time to progression, overall survival. [ Time Frame: 2.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042704
|Principal Investigator:||Robert L Redner, M.D.||University of Pittsburgh Physicians, Hematology/Oncology|