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Multiple MyelomaPhase 1/2NCT01665794

Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 study testing Pomalidomide, Carfilzomib and dexamethasone in people with 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
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Trial summary

The study will investigate the effects of adding carfilzomib to the combination of pomalidomide and dexamethasone in sequential dose escalation cohorts in patients with relapsed or refractory multiple myeloma. This portion of the study is complete. 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?
Pomalidomide, Carfilzomib and dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
5 sitesin 2 countries
Study dates
13 Aug 2012to 14 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Relapsed and relapsed/refractory multiple myeloma requiring systemic therapy
  • Failed at least one prior treatment for multiple myeloma (must have received lenalidomide)
  • To be enrolled as second line therapy: Must be refractory to lenalidomide (progression on therapy or within 60 days of lenalidomide dosing)
  • Measurable disease, as indicated by one or more of the following:
  • Serum M-protein >= 0.5 g/dL
  • Urine M-protein >= 200 mg/24 hours
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  • If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable
  • Involved serum free light chains ≥ 10 mg/dL (free light change ratio must be abnormal)
  • Aged 18 years or older
  • Life expectancy of more than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate Liver Function
  • Bilirubin < 1.5 times the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) < 2.5 times ULN
  • 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 (should be independent of platelet transfusions for at least 2 weeks)
  • Calculated or measured creatinine clearance of >= 30 mL/minute
  • Written informed consent
  • Negative pregnancy test (for women of childbearing potential) within 10-14 days of starting study treatment and again within 24 hours of first pomalidomide dose
  • Must agree to practice abstinence or use two acceptable methods of birth control
  • Men must agree to use latex condom during sexual contact with women of childbearing potential (even if post vasectomy)
  • Must agree to adhere to all study requirements, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring
  • Must register to mandatory POMALYST REMS™ program and be willing and able to comply with the requirements of the POMALYST REMS™ program

Who cannot join

  • Patients for whom there is the prospect of stem cell transplantation in the next 6 months in the treatment plan are excluded
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Plasma cell leukemia
  • Waldenström's macroglobulinemia or immunoglobulin M (IgM) 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
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  • Patients known to be refractory to any proteasome inhibitor other than bortezomib or carfilzomib
  • Pregnant or lactating
  • History of allergy to mannitol or prior hypersensitivity to thalidomide, lenalidomide or pomalidomide
  • Major surgery within 3 weeks prior to first dose,
  • Prior peripheral stem cell transplant within 12 weeks of study enrollment
  • Has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for thyroid conditions or estrogen replacement therapy [ERT]), or any investigational therapy within 21 days of enrollment
  • Myocardial infarction within 6 months prior to enrollment, New York Heart Associate (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 anti fungals within two weeks prior to first dose
  • Known or suspected human immunodeficiency (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 breast, 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
  • Contraindications 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
  • Prior exposure to daratumumab

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

  • Wayne State University - Karmonos Cancer Center

    Detroit, Michigan, 48201

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

Other trials in United States

Canada1 site

  • University Health Network - Princess Margaret Cancer Center

    Toronto, Ontario, MISG 2M9

Other trials in Canada

About this study

Official title: Multicenter, Open-label, Single-arm, Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment With Pomalidomide, Dexamethasone, and Carfilzomib (PdC) in Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma

The study will investigate the effects of adding carfilzomib to the combination of pomalidomide and dexamethasone in sequential dose escalation cohorts in patients with relapsed or refractory multiple myeloma. This portion of the study is complete.

This study will also investigate the effects of adding daratumumab to the combination of carfilzomib, pomalidomide and dexamethasone.

Read the detailed description

Patients receive carfilzomib, pomalidomide, and dexamethasone in 28 days treatment cycles. Study treatment continues for as long a their myeloma does not worsen and they do not have unacceptable side effects. After completion of study treatment, patients are followed for up to 2 years.

Medical subject headings
Multiple Myeloma

What participants receive

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

  • PomalidomideDrug

    Also called CC-4047, Pomalyst(R)

    Pomalidomide taken orally at assigned dose.

  • CarfilzomibDrug

    Also called Kyprolis (R), PR-171

    Carfilzomib given by intravenous (IV) infusion at assigned dose.

  • dexamethasoneDrug

    Also called Aeroseb-Dex, Decaderm, Decadron, DM

    Dexamethasone taken orally of given by IV infusion.

  • DaratumumabDrug

    Also called Daralex

    Daratumumab given by intravenous (IV) infusion at assigned dose.

Study groups in NCT01665794
Study groupRoleWhat they receive
PdC GroupExperimentalPatients receive carfilzomib, pomalidomide, and dexamethasone at indicated doses and schedule every 28 days. Patients may continue to receive treatment in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Pomalidomide; Drug: Carfilzomib; Drug: dexamethasone
PdC + Dara GroupExperimentalPatients receive carfilzomib, pomalidomide, dexamethasone, and daratumumab at indicated doses and schedule every 28 days. Patients may continue to receive treatment in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Pomalidomide; Drug: Carfilzomib; Drug: dexamethasone; Drug: Daratumumab

What is being measured

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

  1. Maximum tolerated dose (MTD) of carfilzomib when administered in combination with pomalidomide and dexamethasone

    Measured: 28 days

  2. Partial response rate after 4 courses according to International Myeloma Working Group (IMWG) criteria

    The proportion and exact 95% binomial confidence interval for the response rate will be reported adjusted for the two-stage design of this trial.

    Measured: 4 months

  3. Response rates of carfilzomib, pomalidomide, dexamethasone, and daratumumab dosing according to International Myeloma Working Group (IMWG) criteria

    Measured: 4 months

Secondary outcomes (5)

  1. Overall response rate

    Defined as at least a partial response to therapy, will be reported along with its exact 95% binomial confidence

    Measured: Up to 2 years

  2. Time to progression

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

    Measured: Up to 2 years

  3. Duration of response

    Assessed conditional upon achieving at least a partial response.

    Measured: From the date of the clinical examination which confirmed the response, until the date of disease progression, or censoring at the date of last clinical follow-up up to 2 years

  4. Progression-free survival

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

    Measured: From the date of first therapy until the date of documented disease progression or death up to 2 years

  5. Overall survival

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

    Measured: Up to 2 years

Timeline

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

  1. First posted15 Aug 2012 (estimated)
  2. Study start13 Aug 2012
  3. Primary completion14 Nov 2025
  4. Study completion14 Nov 2025

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01665794
Sponsor's protocol ID
12-1088
Other IDs
NCI-2012-01168
Status last verified
Nov 2025
First submitted
13 Aug 2012
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes

Publications

  • Derman BA, Zonder J, Reece D, Cole C, Berdeja J, Stefka AT, Major A, Kin A, Griffith K, Jasielec J, Jakubowiak AJ. Phase 1/2 study of carfilzomib, pomalidomide, and dexamethasone with and without daratumumab in relapsed multiple myeloma. Blood Adv. 2023 Oct 10;7(19):5703-5712. doi: 10.1182/bloodadvances.2022008866.

    PubMed 36763537

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pomalidomide, Carfilzomib and dexamethasone in people with 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 25 inclusion and 25 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 22 Dec 2025. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose (MTD) of carfilzomib when administered in combination with pomalidomide and dexamethasone (time frame: 28 days). The study lists 3 primary outcomes in all. 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 NCT01665794, which also lists 1 linked publication.

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 22 Dec 2025.

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