Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Conditions

• Plasma Cell Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bortezomib — DRUG
  Given SC or IV
• Carfilzomib — DRUG
  Given IV
• Dexamethasone — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Optional correlative studies
• Lenalidomide — DRUG
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. 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. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma

Key Dates

First listed

May 29, 2013

Start date

Dec 6, 2013

Status verified

Sep 2025

Primary completion

Dec 31, 2026

Completion

Feb 5, 2034

Study Design

Enrollment

1,087 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (bortezomib, lenalidomide, dexamethasone)
  Patients receive bortezomib SC or IV on days 1, 4, 8, and 11 of courses 1-8 and days 1 and 8 of courses 9-12; lenalidomide PO daily on days 1-14; and dexamethasone PO daily on days 1, 2, 4, 5, 8, 9, 11, and 12 of courses 1-8 and days 1, 2, 8, and 9 of courses 9-12. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (carfilzomib, lenalidomide, dexamethasone)
  Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16; lenalidomide PO daily on days 1-21; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm C (lenalidomide)
  Patients receive lenalidomide PO daily on days 1-21. Treatment repeats every 4 weeks for 24 courses in the absences of disease progression or unacceptable toxicity.
• Experimental: Arm D (lenalidomide)
  Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall survival (OS) for the maintenance analysis [ Time Frame: From the maintenance randomization to death due to any cause or, censored at the date last known alive, assessed up to 15 years ]

Locations (909)

Find similar trials in Anchorage, AK

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