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Multiple MyelomaPhase 2NCT03556332

A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation

A Phase 2 study testing Carfilzomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to test any good and bad effects of giving a combination of study drugs before and after autologous stem cell transplant. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Carfilzomib, Lenalidomide and Dexamethasone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
12 sitesUnited States
Study dates
2 Jul 2018to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be capable, willing, and able to provide written, informed consent.
  • Age ≥ 18-years-old and <= 75-years-old.
  • Histologic confirmation of multiple myeloma by the enrolling institution
  • Symptomatic myeloma that has progressed/relapsed after 1 to 3 prior lines of therapy
  • Patients who have received <=1 cycle of therapy after most recent progression/relapse are eligible to enroll on study
  • Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted
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  • Bisphosphonates are permitted
  • Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted
  • Prior treatment with radiotherapy is permitted
  • 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
  • Maintenance single agent imid (ie. lenalidomide or pomalidomide) or monoclonal antibody (ie. daratumumab) do not require the 4-week washout period
  • More than 2 x 10^6 autologous CD34+ cells/kg cryopreserved. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center.
  • Planning to receive autologous HCT per institutional standards as part of standard of care. Eligibility for autologous HCT should be based on institutional guidelines.
  • However, at minimum all patients must meet the following criteria:
  • KPS greater than 70
  • Cardiac left ventricular ejection fraction of greater than 40%
  • Calculated creatinine clearance of greater than 40 cc/min
  • AST and ALT of less than 2 x upper limit of normal
  • Direct bilirubin of less than 2 x upper limit of normal
  • Total bilirubin of less than 2 x upper limit of normal. If Total bilirubin is abnormal. Direct bilirubin of less than 2 x upper limit of normal
  • Measurable disease as defined by any of the following International Myeloma Working Group Criteria
  • Monoclonal serum peak of greater than 0.5 gms per deciliter
  • Measurable urine peak as defined by urine protein electrophoresis of greater than 100 mg per 24 hours
  • Serum FLC assay: involved FLC level ≥10 mg/dL provided serum FLC ratio is abnormal
  • Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior to enrollment (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines)
  • Platelet count ≥ 50 × 109/L (≥ 30 × 109/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to initial treatment (subjects may be receiving platelet transfusions in accordance with institutional guidelines) .
  • Women of childbearing potential (WOCBP) † must agree to ongoing pregnancy testing and to practice contraception as described in section 9.3 and required by the Revlimid REMS program.
  • † A woman of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy or 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).
  • Male subjects must agree to practice contraception
  • All study participants must be registered into the mandatory Revlimid REMS program and be willing and able to comply with the requirements of the REMS program.

Who cannot join

  • Plasma cell leukemia (>20% circulating plasma cells) during screening studies
  • POEMS syndrome
  • 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
  • Patients with HBV core antibody positive, but HBV PCR negative are eligible if they are on medication for suppression of HBV reactivation
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  • Patients with HCV antibody positive, but PCR negative are eligible.
  • Serologically positive HIV (testing required during screening)
  • 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 >50 mm Hg
  • Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is < 50% of predicted normal.
  • Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.
  • Refractory GI disease 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
  • Prior Allogeneic HCT (prior autologous transplant is allowed regardless of response)
  • History of CNS involvement by myeloma
  • Disease progression as defined by IMW Criteria1 on the combination of carfilzomib, lenalidomide and dexamethasone (Patients with progression on lenalidomide maintenance after completion of carfilzomib, lenalidomide and dexamethasone combination therapy will be eligible).
  • Disease progression on daratumumab
  • Prior dose limiting toxicity from carfilzomib or lenalidomide.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Northwell Health

    Manhasset, New York, 11030

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin (Data Collection Only)

    Milwaukee, Wisconsin, 53226

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • New York University

    New York, New York, 10010

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

  • Wake Forest University (Data Collection Only)

    Winston-Salem, North Carolina, 27109

Other trials in United States

About this study

Official title: Phase 2 Trial of Intensive Chemo-immunotherapy With Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Relapsed/Refractory Myeloma in the Context of Salvage Autologous Hematopoietic Cell Transplantation

The purpose of this study is to test any good and bad effects of giving a combination of study drugs before and after autologous stem cell transplant.

Being tested
Carfilzomib, Lenalidomide, Dexamethasone, Daratumumab, autologous hematopoietic cell transplantation
Keywords
Carfilzomib, Lenalidomide, Dexamethasone, Daratumumab, salvage autologous hematopoietic cell transplantation, 17-493
Medical subject headings
Multiple Myeloma

What participants receive

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

  • CarfilzomibDrug

    Dara-CRd Induction Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 27 mg/m2 per dose, days 8, 9, 15, and 16 Cycles 2-4: Carfilzomib 27 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 Dara-CRd Consolidation (60-90 days post HCT) Cycles 5-8: Carfilzomib 27 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16

  • LenalidomideDrug

    Dara-CRd Induction Cycles 1-4: Lenalidomide 25 mg/day, days 1-21 every 28 days Dara-CRd Consolidation (60-90 days post HCT) Cycles 5-8: Lenalidomide 25 mg/day, days 1-21 every 28 days

  • DexamethasoneDrug

    Dara-CRd Induction Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, 23 Dara-CRd Consolidation (60-90 days post HCT) Cycles 5-8: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, 23

  • DaratumumabDrug

    Dara-CRd Induction Cycles 1 and 2: Daratumumab 16 mg/kg weekly (days 1,8, 15, 22) Dara-CRd Consolidation (60-90 days post HCT)

    Cycles 3 and 4: Daratumumab 16 mg/kg every other week, days 1 and 15.

    Cycles 5-6:Daratumumab 16 mg/kg every other week, days 1 and 15. Schedule together with Carfilzomib and use scheduled dexamethasone as premed.

    Cycles 7-8: Daratumumab 16 mg/kg days 1 of each cycle.

  • autologous hematopoietic cell transplantationProcedure or surgery

    High Dose Melphalan and Autologous Hematopoietic Cell Transplantation Patients will receive Melphalan 200 mg/m2 per institutional guidelines, or if over 70 years of age or creatinine >2mg/dL, they will receive 140 mg/m2.

Study groups in NCT03556332
Study groupRoleWhat they receive
Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab & HCTExperimentalAfter receiving four 28-day cycles of Dara-CRd, eligible patients will then undergo HCT with high dose melphalan conditioning. Sixty to ninety days after HCT, patients will receive another 4 cycles of Dara-CRd.
Receives: Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Daratumumab; Procedure: autologous hematopoietic cell transplantation

What is being measured

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

  1. number of patients with complete remission (CR) rate

    Traditional Response Criteria from International Myeloma Working Group Criteria for Multiple Myeloma

    Measured: 3 years

Timeline

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

  1. First posted14 Jun 2018
  2. Study start2 Jul 2018
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm, Simon two-stage phase II trial of combination therapy
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556332
Sponsor's protocol ID
17-493
Status last verified
Jun 2026
First submitted
1 Jun 2018
Last updated
17 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carfilzomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 12 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 30 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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 complete remission (CR) rate (time frame: 3 years). 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 NCT03556332.

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 17 Jun 2026.

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