Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Stage III Multiple Myeloma Clinical Trial

Official title: Phase 2 Study of the Initial and Post-Transplant Treatment With Carfilzomib, Lenalidomide and Low Dose Dexamethasone (CRd) in Transplant Candidates With Newly Diagnosed, Multiple Myeloma Requiring Systemic Chemotherapy

Status Active, not recruiting

Clinical Trial Summary

This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant works in treating patients with newly diagnosed multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 diving. Giving carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant may kill more cancer cells

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the rate of stringent complete response (CR) (sCR) after 8 cycles of CRd (4 cycles of induction + autologous stem cell transplant [ASCT] + 4 cycles of carfilzomib, lenalidomide, and low dose dexamethasone [CRd] consolidation).

SECONDARY OBJECTIVES:

I. Overall response rate defined as partial response or better (>= partial response [PR]) including the rate of very good partial response (VGPR) or better (>= VGPR) and near complete response or better (sCR/CR/nCR) across entire treatment in high risk and low risk patients.

II. Duration of response (DOR), progression free survival (PFS), time to progression (TTP), and overall survival (OS).

TERTIARY OBJECTIVES:

I. Determination of the rate of minimal residual disease in patients who achieved CR.

II. Prospective evaluation of candidate markers of response to CRd established in the completed CRd trial.

III. Evaluation of markers of response and duration of response to treatment strategy using CRd with or without transplant.

OUTLINE:

INDUCTION THERAPY: Patients receive dexamethasone intravenously (IV) or orally (PO) once daily (QD) on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity..

TRANSPLANT: Patients undergo autologous stem cell transplant.

CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

• NCT number: NCT01816971
• Study type: Interventional
• Source: University of Chicago
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2013
• Completion date: December 1, 2026