NCT02971410

Simvastatin in Overcoming Chemotherapy Resistance in Patients With Relapsed or Refractory Multiple Myeloma

Overcoming Chemotherapy Resistance in Refractory Multiple Myeloma With Simvastatin, A Pilot Study

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies how well simvastatin works in overcoming chemotherapy resistance in patients with multiple myeloma that has come back or does not respond to treatment. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To examine the effect of simvastatin on myeloma (M)-protein and/or free light chains ratio when added to conventional chemotherapy for the treatment of multiple myeloma patients who have received up to 3 (=\< 3) and \> 3 different chemotherapy regimens. (group A and group B) SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS), time to progression (TTP), and duration of response (DOR) in group A, group B, and both groups combined. II. To describe toxicities (frequency and severity during the treatment) in group A, group B, and both groups combined. III. To estimate overall response (OR) in group A, group B, and both groups combined. IV. To evaluate the quality of life (QoL) of patients on the combined treatment in group A, group B, and both groups combined. OUTLINE: Patients receive standard of care chemotherapy for up to 3 courses and simvastatin orally (PO) daily 2 days before the first dose of chemotherapy for up to 2 days after the last dose of chemotherapy. Treatment with simvastatin continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 3-5 weeks for the first 6 months, and every 1-3 months thereafter.

Conditions

• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
DRUG	Simvastatin	Given PO

Timeline

• Start date: 2017-04-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2016-11-23
• Last updated: 2018-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study