Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

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Lymphoproliferative Disorders

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Anti-Inflammatory Agents

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All Drugs and Chemicals

Dexamethasone

Lenalidomide

Daratumumab

Dexamethasone acetate

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Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Carfilzomib Lenalidomide Daratumumab Dexamethasone

Carfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT)

Induction = 8 cycles Carfilzomib on Day 1st, 8th and 15th Lenalidomide: Day 1 to 21

Daratumumab:

Cycles 1-2: weekly Cycles 3-4: every two weeks Cycles 5-8: every month Dexamethasone: 40 mg weekly

Daratumumab Only Product in Parenteral Dose Form

Carfilzomib in combination with lenalidomide, daratumumab and dexamethasone (KRDd) can induce profound clinical responses. The investigators want to observe the effectiveness of the quadruple therapy of carfilzomib, lenalidomide, daratumumab and dexamethasone on patients receiving 8 cycles of KRDd with autologous stem cell transplantation versus patients with 8 cycles of KRDd without autologous stem cell transplantation.

Patients with newly diagnosed and previously untreated multiple myeloma living in Mexico that are fit for a quadruple therapy for multiple myeloma. Those patients that aren't fit or unavailable for transplant will go to the continuous treatment arm. The stratification of the study will be done by age and by cytogenetic risk.

Carfilzomib, Daratumumab, Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma

Complete response with MRD-negative disease measured by inmunophenotype with the International Myeloma Working Group response criteria

Overall survival measured on months on both study groups

Progression free survival measured on months from the time to the end of treatment to disease progression on both study groups

Rate of adverse events rated grade ≥3 by CTCAE 5.0

Grupo Cooperativo de Hemopatías Malignas

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Carfilzomib, Daratumumab, Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma	NCT04288765	Multiple Myelom...	Daratumumab Onl...	18 Years - 65 Years	Grupo Cooperativo de Hemopatías Malignas
Carfilzomib, Daratumumab, Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma	NCT04288765	Multiple Myelom...	Daratumumab Onl...	18 Years - 65 Years	Grupo Cooperativo de Hemopatías Malignas

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