Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients… (NCT03252600) | Clinical Trial Compass
UnknownPhase 2
Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary Amyloidosis
United States53 participantsStarted 2017-08-25
Plain-language summary
This randomized phase II trial studies how well lenalidomide, dexamethasone, and eotuzumab with or without cyclophosphamide work in treating patients with primary amyloidosis that has come back after a period of improvement. Drugs used in chemotherapy, such as lenalidomide, dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as eotuzumab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide, dexamethasone, and eotuzumab with cyclophosphamide may work better in treating patients with primary amyloidosis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biopsy-proven histochemical diagnosis of amyloid light-chain (AL) amyloidosis based on tissue specimens with Congo red staining or other histologic stain; thioflavin T or S, or crystal violet; tandem mass spec or immunohistochemistry (IHC) confirmation of immunoglobulin-derived amyloidosis is encouraged; cases in which histochemical confirmation is lacking need to be discussed with one of the Multiple Myeloma Research Foundation (MMRF) protocol chair/co-chairs
* One prior line of therapy (defined as either one non-transplant regimen such as MelDex, Vel-Dex or CyBorD, one autologous stem cell transplant, or one regimen of non-transplant induction therapy followed by a single autologous stem cell transplant (without hematologic progression between induction and autologous stem cell transplant \[ASCT\])
* Measurable hematologic disease as defined by:
* Serum differential free light chain concentration (dFLC, difference between amyloid forming \[involved\] and non-amyloid forming \[uninvolved\] free light chain \[FLC\]) \>= 50 mg/L)
* Objective measurable (cardiac, renal or liver) organ amyloid involvement defined as follows (amyloid involvement of at least 1 required):
* Mean wall thickness \> 12 mm on echocardiogram, with no other cardiac cause or an elevated NT-ProBNP (\> 332 ng/L) in the absence of renal failure or atrial fibrillation
* Renal involvement is defined as proteinuria (predominantly albumin) \> 0.5 g/day in a 24-hour urine collection…
What they're measuring
1
Major hematologic response (>= very good partial response), or better