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Stage I Multiple MyelomaPhase 2NCT01816971

Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

A Phase 2 study testing dexamethasone, carfilzomib and lenalidomide in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by University of Chicago at 5 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant works in treating patients with newly diagnosed multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
dexamethasone, carfilzomib and lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
5 sitesin 2 countries
Study dates
Jan 2013to 30 Mar 2026
Phase
Phase 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, myeloma requiring systemic chemotherapy as per International Myeloma Working Group (IMWG) uniform criteria:
  • Prior treatment of hypercalcemia or spinal cord compression or active and/or aggressively progressing myeloma with corticosteroids or lenalidomide or bortezomib-based regimens does not disqualify the patient (the treatment dose should not exceed the equivalent of 160 mg of dexamethasone in a 4 week period or not more than 1 cycle)
  • Bisphosphonates are permitted
  • Suitable and interested to proceed to ASCT
  • Measurable disease, prior to initial treatment as indicated by one or more of the following:
  • Serum monoclonal (M)-protein >= 0.5 g/dL
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  • Urine M-protein >= 200 mg/24 hours
  • If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable
  • Life expectancy of more than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Bilirubin < 1.5 times the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times ULN
  • Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
  • Hemoglobin >= 8 g/dL
  • Platelet count >= 75 x 10^9/L; subjects may receive red blood cell (RBC) transfusions or platelet transfusions, if clinically indicated in accordance with institutional guidelines; however, screening platelet count should be independent of platelet transfusions for at least 2 weeks
  • Calculated or measured creatinine clearance of >= 50 mL/minute, calculated using the formula of Cockcroft and Gault
  • Written informed consent in accordance with federal, local, and institutional guidelines
  • Females of childbearing potential (FCBP) (defined as sexually mature females who: have not undergone a hysterectomy or bilateral oophorectomy; or have not been naturally postmenopausal for at least 24 consecutive months [ie, has had menses at any time in the preceding 24 consecutive months]) must agree to ongoing pregnancy testing
  • 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 day 1 cycle 1 and the second pregnancy test must be performed within 24 hours of day 1 cycle 1; the subject may not receive lenalidomide until the treating investigator has verified that the results of these pregnancy tests are negative, and must agree to ongoing pregnancy tests as outlined in the protocol
  • 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:
  • For at least 28 days before starting lenalidomide
  • While participating in the study; and
  • For at least 28 days after discontinuation from the study; the 2 methods of reliable contraception must include a highly effective method (ie, intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and an additional effective (barrier) method (ie, latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed
  • 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
  • Male subjects must agree to inform his physician if he has had unprotected sexual contact with a female who can become pregnant or if he thinks for any reason that his sexual partner may be pregnant
  • Male subjects must agree not to donate semen or sperm while taking lenalidomide
  • All study participants must be registered into the mandatory Rev Assist program and be willing and able to comply with the requirements of Rev Assist
  • The ability to take aspirin or other appropriate venous thromboembolism (VTE) prophylaxis
  • Subjects must agree to adhere to all study requirements, including birth control measures and pregnancy testing, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring

Who cannot join

  • Non-secretory or hyposecretory multiple myeloma, prior to initial treatment defined as < 0.5 g/dL M-protein in serum, < 200 mg/24 hr urine M-protein, or disease only measured by serum free light chain
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Waldenstrom's macroglobulinemia or immunoglobin (Ig)M myeloma
  • Radiotherapy to multiple sites or immunotherapy within 4 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
  • Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is greater
  • Pregnant or lactating females
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  • History of allergy to mannitol
  • Major surgery within 3 weeks prior to first dose
  • Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Uncontrolled hypertension or diabetes
  • Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
  • Known or suspected human immunodeficiency virus (HIV) infection, known HIV seropositivity
  • Active hepatitis A, B, or C infection
  • Non-hematologic malignancy within the past 3 years except 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
  • Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
  • Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
  • Contraindication to any of the required concomitant drugs, including proton-pump inhibitor (eg, lansoprazole), enteric-coated aspirin, allopurinol or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
  • Subjects in whom the required program of PO and IV fluid hydration is contraindicated, eg, due to pre-existing pulmonary, cardiac, or renal impairment
  • Subjects with known or suspected amyloidosis of any organ
  • Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
  • No coverage or not-acceptable by patient co-pay for lenalidomide

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • Dana Farber

    Boston, Massachusetts, 02215

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Washington University in St Louis

    St Louis, Missouri, 63130

Other trials in United States

Canada1 site

  • Princess Margaret

    Toronto, Ontario, M5T 2M9

Other trials in Canada

About this study

Official title: Phase 2 Study of the Initial and Post-Transplant Treatment With Carfilzomib, Lenalidomide and Low Dose Dexamethasone (CRd) in Transplant Candidates With Newly Diagnosed, Multiple Myeloma Requiring Systemic Chemotherapy

This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant works in treating patients with newly diagnosed multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from diving. Giving carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant may kill more cancer cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the rate of stringent complete response (CR) (sCR) after 8 cycles of CRd (4 cycles of induction + autologous stem cell transplant [ASCT] + 4 cycles of carfilzomib, lenalidomide, and low dose dexamethasone [CRd] consolidation).

SECONDARY OBJECTIVES:

  1. Overall response rate defined as partial response or better (>= partial response [PR]) including the rate of very good partial response (VGPR) or better (>= VGPR) and near complete response or better (sCR/CR/nCR) across entire treatment in high risk and low risk patients.

II. Duration of response (DOR), progression free survival (PFS), time to progression (TTP), and overall survival (OS).

TERTIARY OBJECTIVES:

  1. Determination of the rate of minimal residual disease in patients who achieved CR.

II. Prospective evaluation of candidate markers of response to CRd established in the completed CRd trial.

III. Evaluation of markers of response and duration of response to treatment strategy using CRd with or without transplant.

OUTLINE:

INDUCTION THERAPY: Patients receive dexamethasone intravenously (IV) or orally (PO) once daily (QD) on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity..

TRANSPLANT: Patients undergo autologous stem cell transplant.

CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Being tested
dexamethasone, carfilzomib, lenalidomide, autologous hematopoietic stem cell transplantation, laboratory biomarker analysis
Medical subject headings
Multiple Myeloma

What participants receive

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

  • dexamethasoneDrug

    Also called Aeroseb-Dex, Decaderm, Decadron, DM

    Given IV or PO

  • carfilzomibDrug

    Also called Kyprolis, PR-171

    Given IV

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given PO

  • autologous hematopoietic stem cell transplantationProcedure or surgery

    Undergo autologous hematopoietic stem cell transplant

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01816971
Study groupRoleWhat they receive
Treatment (dexamethasone, carfilzomib, lenalidomide)ExperimentalINDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: dexamethasone; Drug: carfilzomib; Drug: lenalidomide; Procedure: autologous hematopoietic stem cell transplantation; Other: laboratory biomarker analysis

What is being measured

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

  1. Percentage of Patients Achieving sCR

    The percentage of stringent complete response (CR) (sCR) will be reported along with 95% confidence intervals, adjusted for the two-stage nature of the trial design.

    Measured: Day 224

Secondary outcomes (5)

  1. Overall Response Rate, Defined as at Least a Partial Response to Therapy (> PR), at Least Very Good Partial Response (VGPR) and at Least Near Complete Response (nCR) Rate

    Reported along with its exact 95% binomial confidence interval.

    Measured: Up to 5 years

  2. Time to Progression

    Estimated using the product-limit method of Kaplan and Meier.

    Measured: Up to 5 years

  3. Duration of Response

    Reported along with its exact 95% binomial confidence interval. Estimated using the product-limit method of Kaplan and Meier.

    Measured: Up to 5 years

  4. Percentage of Participants With Progression-free Survival (PFS)

    Progression-free Survival rate was estimated at months 12, 24, 36, 48, and 60, by the product-limit method of Kaplan and Meier.

    Measured: Up to 5 years

  5. Percentage of Participants With Overall Survival (OS)

    Overall survival rate was estimated at months 12, 24, 36, 48, and 60, by the product-limit method of Kaplan and Meier.

    Measured: Up to 5 years

Timeline

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

  1. First posted22 Mar 2013 (estimated)
  2. Study startJan 2013
  3. Primary completion1 Apr 2018
  4. Study completion30 Mar 2026

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
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01816971
Sponsor's protocol ID
12-1725
Other IDs
NCI-2012-02023
Status last verified
Mar 2026
First submitted
20 Mar 2013
Last updated
21 Apr 2026
Data monitoring committee
No

Publications

  • Landgren O, Kazandjian D, Roussel M, Jasielec J, Dytfeld D, Anderson A, Kervin TA, Iskander K, McFadden I, Jakubowiak AJ. Efficacy and safety of carfilzomib-lenalidomide-dexamethasone in newly diagnosed multiple myeloma: pooled analysis of four single-arm studies. Leuk Lymphoma. 2022 Oct;63(10):2413-2421. doi: 10.1080/10428194.2022.2068001. Epub 2022 May 12.

    PubMed 35549810

  • Jasielec JK, Kubicki T, Raje N, Vij R, Reece D, Berdeja J, Derman BA, Rosenbaum CA, Richardson P, Gurbuxani S, Major S, Wolfe B, Stefka AT, Stephens L, Tinari KM, Hycner T, Rojek AE, Dytfeld D, Griffith KA, Zimmerman TM, Jakubowiak AJ. Carfilzomib, lenalidomide, and dexamethasone plus transplant in newly diagnosed multiple myeloma. Blood. 2020 Nov 26;136(22):2513-2523. doi: 10.1182/blood.2020007522.

    PubMed 32735641

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dexamethasone, carfilzomib and lenalidomide in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by University of Chicago at 5 sites in 2 countries.

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 29 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 23 Sep 2022). 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?

Percentage of Patients Achieving sCR (time frame: Day 224). 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 NCT01816971, which also lists 2 linked publications.

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 21 Apr 2026.

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