NCT02659293

Brief Summary

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3 multiple-myeloma

Timeline
17mo left

Started Apr 2016

Longer than P75 for phase_3 multiple-myeloma

Geographic Reach
2 countries

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Apr 2016Nov 2027

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 26, 2016

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

11.5 years

First QC Date

January 15, 2016

Last Update Submit

March 2, 2026

Conditions

Multiple Myeloma

Keywords

Multiple myelomastem-cell transplantSymptomatic myelomalenalidomidecarfilzomibdexamethasone

Outcome Measures

Primary Outcomes (1)

  • Progression free survival rates in participants receiving drug combination

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

    4 years

Secondary Outcomes (3)

  • Rate of minimal residual negative disease (MRD) in participants receiving drug combination

    3 years

  • Response rate in participants receiving drug combination

    3 years

  • Treatment-related side effects

    From date of screening until end of treatment

Study Arms (2)

Lenalidomide (Control)

ACTIVE COMPARATOR

Treatment with lenalidomide only

Drug: Lenalidomide (Control)

Experimental Combination Regimen

EXPERIMENTAL

Experimental arm using a combination of Carfilzomib, Lenalidomide and Dexamethasone

Drug: LenalidomideDrug: CarfilzomibDrug: Dexamethasone

Interventions

LenalidomideDRUG

* 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

Also known as: Revlimid
Experimental Combination Regimen
CarfilzomibDRUG

* 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

Also known as: Kyprolis
Experimental Combination Regimen
DexamethasoneDRUG

* 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

Experimental Combination Regimen
Lenalidomide (Control)DRUG

* 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

Also known as: Revlimid
Lenalidomide (Control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who completed single autologous stem cell transplant after completion of at most 2 induction regimens (excluding dexamethasone alone) and are in at least stable disease in the first 100 days after stem cell transplantation.
  • Patients must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimens.
  • Bone marrow specimen will be required at study entry; available DNA sample will be used for calibration step for MRD evaluation by gene sequencing.
  • Males and females ≥ 18 years of age
  • ECOG performance status of 0-1
  • Adequate hepatic function, with bilirubin ≤ 1.5 x ULN and aspirate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
  • ANC ≥ 1.0 x 109/L, hemoglobin ≥ 8 g/dL, platelet count ≥ 75 x 109/L.
  • Calculated creatinine clearance (by Cockcroft-Gault) ≥ 50 ml/min or serum creatinine below 2 mg/dL
  • Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide. The first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for Cycle 1 (prescriptions must be filled within 7 days).
  • FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
  • UCM IRB CRd vs. R Version 1.0 Page 11
  • Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
  • All study participants in the US must be consented to and registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS®.
  • Voluntary written informed consent

You may not qualify if:

  • Patients who progressed after initial therapy.
  • Subjects whose therapy changed due to suboptimal response, intolerance, etc., remain eligible, provided they do not meet criteria for progression.
  • No more than two regimens for induction will be allowed excluding dexamethasone alone.
  • Evidence of progressive disease as per International Myeloma Working Group (IMWG) criteria
  • Patients who have already started or received post-transplant maintenance or consolidation regimen
  • Patients not able to tolerate lenalidomide or carfilzomib or dexamethasone
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Plasma cell leukemia
  • Waldenström's macroglobulinemia or IgM myeloma
  • Peripheral neuropathy ≥ Grade 2 at screening
  • Diarrhea \> Grade 1 in the absence of antidiarrheals
  • CNS involvement
  • Pregnant or lactating females
  • Radiotherapy within 14 days before randomization. Seven days may be considered if to single area.
  • Major surgery within 3 weeks prior to first dose
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Wayne State University - Karmanos Cacner Institute

Detroit, Michigan, 48201, United States

Location

Polish Myeloma Consortium

Poznan, Poland

Location

Related Publications (4)

  • Dytfeld D, Wrobel T, Jamroziak K, Kubicki T, Robak P, Pula A, Walter-Croneck A, Czyz J, Tyczynska A, Druzd-Sitek A, Giannopoulos K, Nowicki A, Szczepaniak T, Lojko-Dankowska A, Matuszak M, Gil L, Pula B, Rybka J, Majcherek M, Usnarska-Zubkiewicz L, Szukalski L, Konska A, Zaucha JM, Walewski J, Mikulski D, Czabak O, Robak T, Lahoud OB, Zonder JA, Cooperrider JH, Derman BA, Karrison T, Jakubowiak AJ. Carfilzomib, lenalidomide, and dexamethasone compared with lenalidomide treatment after autologous haematopoietic stem-cell transplantation in patients with multiple myeloma (ATLAS): primary analysis of a randomised, open-label, phase 3 trial. Lancet Haematol. 2026 Mar 11:S2352-3026(26)00011-6. doi: 10.1016/S2352-3026(26)00011-6. Online ahead of print.

    PMID: 41831471DERIVED

  • Kubicki T, Jamroziak K, Robak P, Czyz J, Tyczynska A, Druzd-Sitek A, Giannopoulos K, Wrobel T, Nowicki A, Szczepaniak T, Lojko-Dankowska A, Matuszak M, Gil L, Pula B, Szukalski L, Konska A, Zaucha JM, Walewski J, Mikulski D, Czabak O, Robak T, Kruk-Kwapisz D, Derman BA, Major A, Jakubowiak AJ, Dytfeld D. Health-related quality of life in patients with multiple myeloma treated in the phase 3 ATLAS trial of post-transplant maintenance with carfilzomib, lenalidomide, and dexamethasone or lenalidomide alone. Pol Arch Intern Med. 2024 May 28;134(5):16749. doi: 10.20452/pamw.16749. Epub 2024 May 14. No abstract available.

    PMID: 38747414DERIVED

  • Kubicki T, Dytfeld D, Barnidge D, Sakrikar D, Przybylowicz-Chalecka A, Jamroziak K, Robak P, Czyz J, Tyczynska A, Druzd-Sitek A, Giannopoulos K, Wrobel T, Nowicki A, Szczepaniak T, Lojko-Dankowska A, Matuszak M, Gil L, Pula B, Szukalski L, Konska A, Zaucha JM, Walewski J, Mikulski D, Czabak O, Robak T, Jiang K, Cooperrider JH, Jakubowiak AJ, Derman BA. Mass spectrometry-based assessment of M protein in peripheral blood during maintenance therapy in multiple myeloma. Blood. 2024 Aug 29;144(9):955-963. doi: 10.1182/blood.2024024041.

    PMID: 38713888DERIVED

  • Dytfeld D, Wrobel T, Jamroziak K, Kubicki T, Robak P, Walter-Croneck A, Czyz J, Tyczynska A, Druzd-Sitek A, Giannopoulos K, Nowicki A, Szczepaniak T, Lojko-Dankowska A, Matuszak M, Gil L, Pula B, Rybka J, Majcherek M, Usnarska-Zubkiewicz L, Szukalski L, Konska A, Zaucha JM, Walewski J, Mikulski D, Czabak O, Robak T, Lahoud OB, Zonder JA, Griffith K, Stefka A, Major A, Derman BA, Jakubowiak AJ. Carfilzomib, lenalidomide, and dexamethasone or lenalidomide alone as maintenance therapy after autologous stem-cell transplantation in patients with multiple myeloma (ATLAS): interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023 Feb;24(2):139-150. doi: 10.1016/S1470-2045(22)00738-0. Epub 2023 Jan 12.

    PMID: 36642080DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

LenalidomidecarfilzomibDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Andrzej Jakubowiak, MD, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

April 26, 2016

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(2)PL(1)