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Multiple MyelomaPhase 1/2NCT02937571

High Dose Carfilzomib for Newly Diagnosed Myeloma

A Phase 1/2 study testing Carfilzomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test whether giving high doses of carfilzomib along with the other drugs (lenalidomide and dexamethasone) is safe and which dose is best tolerated by patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Carfilzomib, Lenalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
6 sitesUnited States
Study dates
Oct 2016to 8 Oct 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed patients with histologically confirmed MM based on the following criteria:
  • Clonal plasma cells in the bone marrow
  • Measurable disease within the past 4 weeks defined by any one of the following:
  • Serum monoclonal protein ≥ 1.0 g/dL
  • Urine monoclonal protein >200 mg/24 hour
  • Involved serum immunoglobulin free light chain > 10 mg/dL AND abnormal kappa/lambda ratio
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  • Evidence of underlying end organ damage and/or myeloma defining event attributed to underlying plasma cell proliferative disorder meeting at least one of the following:
  • Hypercalcemia: serum calcium >0.25 mmol/L (> 1 mg/dL) above upper limit of normal or ≥ 2.75 mmol/L (11 mg/dL)
  • Anemia: hemoglobin value <10 g/dL or > 2 g/dL below lower limit of normal
  • Bone disease: ≥ 1 lytic lesions on skeletal X-ray, CT, or PET-CT. For patients with 1 lytic lesion, bone marrow should demonstrate ≥10% clonal plasma cells
  • Clonal bone marrow plasma cell percentage ≥60%
  • Involved/un-involved serum free light chain ratio ≥100 and involved free light chain >100 mg/L.
  • 1 focal lesion on magnetic resonance imaging study (lesion must be >5 mm) in size
  • Creatinine Clearance ≥ 60 ml/min. CrCl can be measured or estimated using Cockcroft-Gault method
  • Age ≥ 18 years at the time of signing the informed consent documentation
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1.0 K/uL, hemoglobin ≥ 8 g/dL, and platelet count ≥ 75 K/uL, unless if cytopenias are deemed to be due disease at discretion of clinical investigator. Transfusions and growth factors are permissible.
  • Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 3.0 x ULN.
  • All study participants must be able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (coumadin) or alternative anti-coagulant.
  • All study participants must be registered into the mandatory eREMS® program, and be willing and able to comply with the requirements of REMS®.
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
  • A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Who cannot join

  • Patients receiving >1 cycle of prior treatment or concurrent systemic treatment for multiple myeloma.
  • Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted
  • Bisphosphonates are permitted
  • Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted
  • Prior treatment with radiotherapy is permitted
  • Prior treatment for smoldering myeloma is permitted with a washout period of 4 weeks from last dose. Smoldering patients previously treated with carfilzomib are excluded.
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  • Patients with measurable disease who received up to one cycle of any therapy within 60 days with a washout period of 4 weeks from last dose (on a trial or outside a trial) are eligible
  • Plasma cell leukemia
  • POEMS syndrome
  • Amyloidosis
  • Pregnant or lactating females. Because there is a potential risk for adverse events nursing infants secondary to treatment of the mother with carfilzomib in combination with lenalidomide. These potential risks may also apply to other agents used in this study.
  • Uncontrolled hypertension or diabetes
  • Active hepatitis B or C infection
  • Known or suspected HIV or serologically positive
  • Has significant cardiovascular disease with NYHA Class III or IV symptoms, EF<40% or hypertrophic cardiomyopathy, or restrictive cardiomyopathy, or myocardial infarction within 6 months prior to enrollment, or unstable angina, or unstable arrhythmia as determined by history and physical examination. Echocardiogram will be performed during screening evaluation.
  • Moderate or severe pulmonary hypertension defined as PASP > 50mm Hg. For those patients were PASP is indeterminate, moderate to severe symptoms of pulmonary hypertension (World Health Organization functional assessment class III or IV) will be used to determine exclusion criteria.
  • Has refractory GI disease with refractory nausea/vomiting, inflammatory bowel disease, or bowel resection that would prevent absorption of oral agents
  • Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements
  • Significant neuropathy ≥Grade 3 or Grade 2 neuropathy with pain at baseline
  • Contraindication to any concomitant medication, including antivirals or anticoagulation
  • Major surgery within 3 weeks prior to first dose

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Memorial Sloan Kettering Cancer Center

    Basking Ridge, New Jersey

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Carfilzomib, Lenalidomide, and Dexamethasone in Newly-Diagnosed Multiple Myeloma: A Clinical and Correlative Phase I/II Dose Escalation Study

The purpose of this study is to test whether giving high doses of carfilzomib along with the other drugs (lenalidomide and dexamethasone) is safe and which dose is best tolerated by patients. In addition, the study is designed to test the amount of remaining myeloma cells in the body after treatment with higher carfilzomib doses which is known as minimal residual disease (MRD).

Keywords
Carfilzomib, Lenalidomide, Dexamethasone, 15-326
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02937571
Study groupRoleWhat they receive
Carfilzomib, Lenalidomide, and DexamethasoneExperimental* Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 45 or 56 mg/m2 per dose, days 8, 9, 15, and 16. * Cycles 2- up to 12: Carfilzomib 45 or 56 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 * Cycles 1- up to 12: Lenalidomide 25 mg/day, days 1-21 every 28 days * Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 * Cycles 5- up to 12: Dexamethasone 10 mg/dose, days 1, 2, 8, 9, 15, 16, 22 and 23
Receives: Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Dose Limiting Toxicity

    To find the maximum tolerated dose.A DLT is defined as any of the below toxicities with attribution to one or more of the study drugs that occur during Cycle 1. All AEs should be considered relevant to determining dose-limiting toxicities and to reporting unless the event can clearly be determined to be UNRELATED to the drug. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.

    Measured: Cycle 1, up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion8 Oct 2024
  4. Study completion8 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02937571
Sponsor's protocol ID
15-326
Status last verified
Oct 2024
First submitted
17 Oct 2016
Last updated
20 Nov 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Carfilzomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Dose Limiting Toxicity (time frame: Cycle 1, up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02937571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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