R-(-)-Gossypol Acetic Acid With Lenalidomide and Dexamethasone in Treating Patients With Relapsed Symptomatic Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2022-06-15
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial studies the side effects and best dose of R-(-)-gossypol acetic acid when given together with lenalidomide and dexamethasone and to see how well it works in treating patients with multiple myeloma, also known as plasma cell myeloma, that has come back after a period of improvement or has gotten worse after treatment. R-(-)-gossypol acetic acid may stop the growth of cancer cells by recognizing certain proteins and stimulating programmed cell death. Lenalidomide may stimulate or suppress 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, by stopping them from dividing, or by stopping them from spreading. Giving R-(-)-gossypol acetic acid with lenalidomide and dexamethasone may work better in treating patients with multiple myeloma.

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

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Acetic Acid; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gossypol; Gossypol acetic acid; Lenalidomide; Retinol acetate; Thalidomide

Criteria

Inclusion Criteria:

• Calculated creatinine clearance (using Cockcroft-Gault equation) >= 60 mL/min

• Absolute neutrophil count (ANC) >= 1000/mm^3

• Platelet count >= 75000/mm^3

• Hemoglobin >= 8.0 g/dL

• Patient must have relapsed and symptomatic multiple myeloma

• Measurable disease of multiple myeloma as defined by at least ONE of the following:

• Serum monoclonal protein >= 1.0 g/dL

• > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

• Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

• Patients must have received at least 1 prior regimen

• Provide informed written consent

• Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only

• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

• Willing to provide bone marrow and blood samples for correlative research purposes

Exclusion Criteria:

• Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma

• Patients who have received > 3 prior treatment regimens for multiple myeloma

• Other malignancy requiring active therapy; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer

• Any of the following:

• Pregnant women

• Nursing women

• Men or women of childbearing potential who are unwilling to employ adequate contraception

• Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease

• Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; Note: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment

• Prior severe skin reaction (toxic epidermal necrosis) with immunomodulating agents

• Major surgery =< 14 days before study registration

• Concurrent medical problems that preclude use of deep vein thrombosis (DVT) prophylaxis with lenalidomide treatment

• Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction =< 6 months prior to registration

• Known human immunodeficiency virus (HIV) positive

• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol

• Known allergy to any of the study medications, their analogues or excipients in the various formulations