Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction
(PrE1003 Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: PrECOG, LLC.

No Placebo Group

Trial Summary

What is the purpose of this trial?

Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.

Eligibility Criteria

Inclusion Criteria

Diagnosed with previously treated multiple myeloma.

Serum monoclonal protein ≥1 g by protein electrophoresis

Urine monoclonal protein >200 mg on 24 hour electrophoresis

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Treatment Details

Interventions

Dexamethasone (Corticosteroid)
Lenalidomide (Immunomodulatory Agent)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Group C, CrCl < 30 mL/min, on dialysisExperimental Treatment3 Interventions

Creatinine clearance \< 30 mL/min and on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants.

Group II: Group B, CrCl < 30 mL/minExperimental Treatment3 Interventions

Creatinine clearance \< 30 mL/min, not on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants.

Group III: Group A - CrCl 30-60 mL/minExperimental Treatment3 Interventions

Creatinine clearance 30 - 60 mL/min, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dexamethasone for: