Skip to content
Triangle logo TriangleGet started
← Study library

NCT02659293 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-03-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: 1. 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. 2. Patients must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimens. 3. Bone marrow specimen will be required at study entry; available DNA sample will be used for calibration step for MRD evaluation by gene sequencing. 4. Males and females ≥ 18 years of age 5. ECOG performance status of 0-1 6. Adequate hepatic function, with bilirubin ≤ 1.5 x ULN and aspirate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN 7. ANC ≥ 1.0 x 109/L, hemoglobin ≥ 8 g/dL, platelet count ≥ 75 x 109/L. 8. Calculated creatinine clearance (by Cockcroft-Gault) ≥ 50 ml/min or serum creatinine below 2 mg/dL 9. 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). 10. 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 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. 12. 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®. 13. Voluntary written informed consent Exclusion Criteria: 1. Patients who have had more than 12 months of prior therapy. Patients outside of this window may be considered for inclusion on a case-by-case basis. 2. Patients who progressed after initial therapy. 1. Subjects whose therapy changed due to suboptimal response, intolerance, etc., remain eligible, provided they do not meet criteria for progression. 2. No more than two regimens for induction will be allowed excluding dexamethasone alone. 3. Evidence of progressive disease as per International Myeloma Working Group (IMWG) criteria 4. Patients who have already started or received post-transplant maintenance or consolidation regimen 5. Patients not able to tolerate lenalidomide or carfilzomib or dexamethasone 6. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 7. Plasma cell leukemia 8. Waldenström's macroglobulinemia or IgM myeloma 9. Peripheral neuropathy ≥ Grade 2 at screening 10. Diarrhea \> Grade 1 in the absence of antidiarrheals 11. CNS involvement 12. Pregnant or lactating females 13. Radiotherapy within 14 days before randomization. Seven days may be considered if to single area. 14. Major surgery within 3 weeks prior to first dose 15. Myocardial infarction within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 16. Prior or concurrent deep vein thrombosis or pulmonary embolism 17. Rate-corrected QT interval of electrocardiograph (QTc) \> 470 msec on a 12-lead ECG during screening 18. Uncontrolled hypertension or diabetes 19. Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose 20. Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. 21. Non-hematologic malignancy or non-myeloma hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer \< Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone 22. Any clinically significant medical disease or condition that, in the Treating Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Treatment with lenalidomide only
    intervention Names
    1. Drug: Lenalidomide (Control)
    label
    Lenalidomide (Control)
    type
    ACTIVE_COMPARATOR
  2. description
    Experimental arm using a combination of Carfilzomib, Lenalidomide and Dexamethasone
    intervention Names
    1. Drug: Lenalidomide
    2. Drug: Carfilzomib
    3. Drug: Dexamethasone
    label
    Experimental Combination Regimen
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Experimental Combination Regimen
    description
    * 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
    name
    Lenalidomide
    other Names
    1. Revlimid
    type
    DRUG
  2. arm Group Labels
    1. Experimental Combination Regimen
    description
    * 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
    name
    Carfilzomib
    other Names
    1. Kyprolis
    type
    DRUG
  3. arm Group Labels
    1. Experimental Combination Regimen
    description
    * 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
    name
    Dexamethasone
    type
    DRUG
  4. arm Group Labels
    1. Lenalidomide (Control)
    description
    * 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
    name
    Lenalidomide (Control)
    other Names
    1. Revlimid
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
180
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Measurement of time to disease worsening as measured by International Myeloma Working Group (IMWG) response criteria.
    measure
    Progression free survival rates in participants receiving drug combination
    time Frame
    4 years
secondary Outcomes
  1. description
    Calculation of number of participants with MRD-negative disease.
    measure
    Rate of minimal residual negative disease (MRD) in participants receiving drug combination
    time Frame
    3 years
  2. description
    Number of participants with disease response (e.g. improvement) as measured by International Myeloma Working Group (IMWG) response criteria.
    measure
    Response rate in participants receiving drug combination
    time Frame
    3 years
  3. description
    Number of participants with grade 2 or greater treatment-related side effects as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
    measure
    Treatment-related side effects
    time Frame
    From date of screening until end of treatment
Full study description
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.
detailed Description
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
Source references
references
  1. citation
    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 Apr;13(4):e241-e253. doi: 10.1016/S2352-3026(26)00011-6. Epub 2026 Mar 11.
    pmid
    41831471
    type
    DERIVED
  2. citation
    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
    38747414
    type
    DERIVED
  3. citation
    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
    38713888
    type
    DERIVED
  4. citation
    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
    36642080
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-d65d5d4d7971e87407a6
      requested nct id
      NCT02659293
      primary nct id
      NCT02659293
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      d6d5c80c67e5b4a0e31dcb23f10af8ee613bf3cdea28b12cf6edeec4e8cb5efd
      payload sha256
      4e3e12b68d890c91412bd9d706923c9bcb7be80a6396f3a37858407d8326633b
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-d65d5d4d7971e87407a6
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT02659293
      occurrences
      1. context exact
        sion=HealthProfessional&amp;language=English'); return(false);">Level of evidence B1</a>]</li></ul></div></li><li>A prospective trial (<a href="/clinicaltrials/NCT02659293">NCT02659293</a>) evaluated maintenance therapy in patients with newly diagnosed melanoma who had received induction therapy and autologous SCT. Patients were
        end
        200989
        exact text
        NCT02659293
        start
        200978
      2. context exact
        ofessional&amp;language=English'); return(false);">Level of evidence B1</a>]</li></ul></div></li><li>A prospective trial (<a href="/clinicaltrials/NCT02659293">NCT02659293</a>) evaluated maintenance therapy in patients with newly diagnosed melanoma who had received induction therapy and autologous SCT. Patients were randomly assi
        end
        201002
        exact text
        NCT02659293
        start
        200991
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/f296c0ceec7921f192.html
      source file sha256
      d6d5c80c67e5b4a0e31dcb23f10af8ee613bf3cdea28b12cf6edeec4e8cb5efd
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:22:07.301466+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      06d77adc5701fe0c36d2266d613a483252a6113e6a22b8858db2d23882bdc33b
      source title
      Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025

    Preserved source evidence · Not medical advice