NCT02415413 is a Phase 2 clinical trial of carfilzomib in Smoldering Multiple Myeloma, sponsored by PETHEMA Foundation.

Who is sponsoring NCT02415413?

NCT02415413 is sponsored by PETHEMA Foundation.

What drugs are being tested in NCT02415413?

Interventions in NCT02415413: carfilzomib, Lenalidomide, Dexamethasone, Melphalan.

What condition does NCT02415413 study?

NCT02415413 studies Smoldering Multiple Myeloma.

Is NCT02415413 still recruiting?

NCT02415413 is currently active, enrolled. Last updated 9 September 2022.

Last reviewed 2022-09-09 · How we verify

NCT02415413

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II Multicenter Study of Carfilzomib, Lenalidomide and Dexamethasone (KRd) as Induction Therapy, Followed by High-dose Therapy With Melphalan and Autologous Peripheral Blood Stem Cell Transplantation, Consolidation With KRd, and Maintenance With Lenalidomide and Dexamethasone in Patients ≤ 70 Years Old With Smoldering Multiple Myeloma (SMM) With High Risk of Progression to Symptomatic Myeloma

Active, enrolled Phase 2 Last updated 9 September 2022

What this trial tests

Phase 2 trial testing carfilzomib in Smoldering Multiple Myeloma in 90 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 May 2015

Primary endpoint
5 July 2018

1 June 2027

Quick facts

Lead sponsor	PETHEMA Foundation
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	1 May 2015
Primary completion	5 July 2018
Estimated completion	1 June 2027
Sites	16 locations across Spain

Drugs / interventions tested

carfilzomib (carfilzomib) — full drug profile →
Lenalidomide — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →
Melphalan (melphalan) — full drug profile →

Conditions studied

Smoldering Multiple Myeloma — all drugs for Smoldering Multiple Myeloma →

Sponsor

PETHEMA Foundation

Who can join

Adults 18 to 70, any sex, with Smoldering Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Efficacy- Number of Immunophenotypic complete remission rate (Flow-CR) at day +100 after induction and HDT-ASCT
Time frame: 4 months
Number of Immunophenotypic complete remission rate (Flow-CR) at day +100 after induction and HDT-ASCT

Sponsor's own description

Patients included in the study will receive induction treatment during 6 months, followed by receive high-dose therapy followed by peripheral blood stem cell transplantation. Approximately 3 months after peripheral blood stem cell transplantation patients will receive consolidation treatment during 2 months. Subsequently patients will start maintenance treatment during 24 months. Therefore, the total duration of the treatment will be approximately 36 months.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

A look backward and forward in the regulatory and treatment history of multiple myeloma: Approval of novel-novel agents, new drug development, and longer patient survival.
Kazandjian D, Landgren O. · · 2016 · cited 53× · PMID 28061986 · DOI 10.1053/j.seminoncol.2016.10.008
Smoldering multiple myeloma current treatment algorithms.
Rajkumar SV, Kumar S, Lonial S, Mateos MV. · · 2022 · cited 49× · PMID 36064707 · DOI 10.1038/s41408-022-00719-0
Pursuing a Curative Approach in Multiple Myeloma: A Review of New Therapeutic Strategies.
D'Agostino M, Bertamini L, Oliva S, Boccadoro M, et al · · 2019 · cited 32× · PMID 31847174 · DOI 10.3390/cancers11122015
2021 European Myeloma Network review and consensus statement on smoldering multiple myeloma: how to distinguish (and manage) Dr. Jekyll and Mr. Hyde.
Musto P, Engelhardt M, Caers J, Bolli N, et al · · 2021 · cited 29× · PMID 34261295 · DOI 10.3324/haematol.2021.278519
Curative Strategy for High-Risk Smoldering Myeloma: Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Followed by Transplant, KRd Consolidation, and Rd Maintenance.
Mateos MV, Martínez-López J, Martínez-López J, Rodriguez Otero P, et al · · 2024 · cited 21× · PMID 39038268 · DOI 10.1200/jco.23.02771
Smoldering multiple myeloma: evolving diagnostic criteria and treatment strategies.
Visram A, Cook J, Warsame R. · · 2021 · cited 14× · PMID 34889380 · DOI 10.1182/hematology.2021000304
Early or deferred treatment of smoldering multiple myeloma: a meta-analysis on randomized controlled studies.
Zhao AL, Shen KN, Wang JN, Huo LQ, et al · · 2019 · cited 13× · PMID 31296995 · DOI 10.2147/cmar.s205623
Treatment of Smoldering Multiple Myeloma: Ready for Prime Time?
Kim EB, Yee AJ, Raje N. · · 2020 · cited 9× · PMID 32414145 · DOI 10.3390/cancers12051223

Verify or expand the search:

Other trials of carfilzomib

Trials testing the same drug.

NCT05017545 — Carfilzomib and Belatacept for Desensitization · Phase 1, PHASE2 · active not recruiting
NCT03275285 — Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Rel · Phase 3 · completed
NCT02293109 — Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma · Phase 1 · completed
NCT01738594 — Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma · Phase 1 · terminated
NCT01246063 — Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refr · Phase 1, PHASE2 · completed

Other recruiting trials for Smoldering Multiple Myeloma

Currently open trials in the same condition.

NCT06365060 — Screening for AL Amyloidosis in Smoldering Multiple Myeloma · recruiting
NCT05597345 — Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma · Phase 2 · recruiting
NCT05841550 — The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma · Phase 1, PHASE2 · recruiting
NCT06383143 — Promoting Diagnosis and Management of AL in Italy (ProDigALIty) · recruiting
NCT05767359 — CAR- PRISM (PRecision Intervention Smoldering Myeloma) · Phase 2 · active not recruiting

Other PETHEMA Foundation trials

Trials by the same sponsor.

NCT07443592 — Treatment for Ph-negative ALL for Adults up to 65 Years · NA · not yet recruiting
NCT07045909 — Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST) · Phase 2 · recruiting
NCT06574126 — Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma · Phase 2 · recruiting
NCT06544785 — Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Phase 2 · recruiting
NCT06175702 — Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02415413 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PETHEMA Foundation
Last refreshed: 9 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02415413.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing