NCT01816971

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

Type	Name	Description
DRUG	dexamethasone	Given IV or PO
DRUG	carfilzomib	Given IV
DRUG	lenalidomide	Given PO
PROCEDURE	autologous hematopoietic stem cell transplantation	Undergo autologous hematopoietic stem cell transplant
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-01-01
• Primary completion: 2018-04-01
• Completion: 2026-12-01
• First posted: 2013-03-22
• Last updated: 2025-06-10
• Results posted: 2022-09-23

Locations

5 sites across 2 countries: United States, Canada