Neoplasms

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Multiple Myeloma

Neoplasms, Plasma Cell

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Dexamethasone

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Experimental arm using a combination of Carfilzomib, Lenalidomide and Dexamethasone

* Cycle 1: 15 mg days 1-21
* Cycles 2-4: 25 mg days 1-21 if tolerated, otherwise continue at lower dose
* Cycles 5 and beyond: best tolerated dose days 1-21

* Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8,9 of cycle 1) will be al12,lowed at the treating physician's discretion.
* Cycle 2-4: 36 mg/m2 if tolerated Days 1, 2, 8, 9, 15, 16
* Cycles 5-8 (patients that are MRD- and have no risk factors at the end of cycle 6) and Cycle 5 - 36 (for MRD+ patients and high risk patients at the end of cycle 6): best tolerated dose Days 1, 2, 15, 16

Carfilzomib

* Cycles 1 - 4: 20 mg PO or IV per dose Days 1, 8, 15, 22
* Cycles 5+: 20 mg or best tolerated dose PO or IV per dose Days 1, 8, 15, 22

* Cycles 1-4: Days 1-28. Lenalidomide will begin at a dose of 10 mg PO daily (2 capsules per day). After three months, the dose will be increased, provided ANC ≥ 1,000/µL, platelet count ≥ 75,000/µL, and all nonhematologic toxicity is ≤ grade 1, to 15 mg PO daily (3 capsules per day).
* Cycles 5 and beyond: best tolerated dose days 1-28

Lenalidomide (Control)

Andrzej Jakubowiak, MD, PhD

This is a Phase 3 randomized trial of carfilzomib, lenalidomide, dexamethasone versus lenalidomide alone after stem-cell transplant for multiple myeloma, eligible to subjects who completed autologous stem cell transplant for symptomatic myeloma who are considered for lenalidomide maintenance.

Primary Objective:

* To compare progression free survival between Kyprolis (Carfilzomib), Revlimid (lenalidomide), Dexamethasone (KRd) arm and lenalidomide arm

Secondary Objectives

* To determine the rate of minimal residual negative disease (MRD) at 6 and 12 months after randomization
* To compare the efficacy (rate of partial response, very good partial response, complete response, and stringent complete response) of KRd vs. Lenalidomide alone after randomization

Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma

Phase 3 Randomized Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma

Measurement of time to disease worsening as measured by International Myeloma Working Group (IMWG) response criteria.

Calculation of number of participants with MRD-negative disease.

Number of participants with disease response (e.g. improvement) as measured by International Myeloma Working Group (IMWG) response criteria.

Number of participants with grade 2 or greater treatment-related side effects as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma	NCT02659293	Multiple Myelom...	Lenalidomide Carfilzomib Dexamethasone Lenalidomide (C...	18 Years -	University of Chicago
Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma	NCT02659293	Multiple Myelom...	Lenalidomide Carfilzomib Dexamethasone Lenalidomide (C...	18 Years -	University of Chicago

Spots Global Cancer Trial Database for lenalidomide (control)