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Multiple MyelomaPhase 1/2NCT01464034

A Safety and Efficacy Study of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 study testing Carfilzomib, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Criterium, Inc. at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to evaluate efficacy. 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, Pomalidomide and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
9 sitesUnited States
Study dates
Nov 2011to Jul 2020
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

  • Cytopathologically or histologically confirmed dx of multiple myeloma
  • Relapsed or refractory to the most recently received therapy.
  • All pts must have received prior lenalidomide therapy and been determined to be refractory, relapsed, or intolerant.
  • Measurable disease, as indicated by one or more of the following:
  • Serum M-protein ≥ 0.5 g/dL Urine Bence Jones protein ≥ 200 mg/24 hr Elevated Free Light Chain as per IMWG criteria, and abnormal ratio
  • Pts must be ≥ 18 years of age
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  • Life expectancy of more than 3 months
  • ECOG PS of 0-2
  • Adequate hepatic function, with bilirubin < 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN
  • Uric acid must be within laboratory normal range
  • CrCl ≥ 50 mL/min
  • Additional Laboratory Requirements ANC ≥1.0 x 109/L Hgb ≥8 g/dL(transfusion permitted) Platelet count ≥50.0 x 109/L
  • Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
  • Pts may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines
  • Screening platelet count should be independent of platelet transfusions for at least 2 weeks.
  • Written informed consent in accordance with federal, local, and institutional guidelines
  • FCBP must agree to ongoing pregnancy testing
  • FCBP must have a negative serum or urine pregnancy test and agree to birth control.
  • Male pts must agree to never have unprotected sexual contact with a female who can become pregnant and must agree to either completely abstain from sexual contact with females who are pregnant or are able to become pregnant. The patient 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 pts cannot donate semen or sperm while taking pomalidomide and for 28 days after completing the study.
  • All pts must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • Pts must agree to take enteric-coated aspirin 81 mg orally daily, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE)at the investigator's discretion

Who cannot join

  • Pts with known sensitivity to any immunomodulatory drugs (IMiDs)
  • Use of any other experimental drug or therapy within 21 days prior to first dose
  • Exposure to any prior chemotherapy, steroid use, or other myeloma treatment within 14 days prior to first dose. Pts currently on long term steroids do not require any washout period. in addition, steroid use for spinal cord compression is permitted and does not require a washout period.
  • Radiation therapy within 14 days prior to first dose
  • Known allergies to carfilzomib or Captisol
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
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  • Current diagnosis of plasma cell leukemia
  • Waldenström's macroglobulinemia
  • Major surgery within 21 days prior to first dose
  • Pregnant or lactating females
  • Congestive heart failure (NYHA class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months prior to first dose.
  • Uncontrolled hypertension
  • Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose
  • Pts receiving active treatment or intervention for any other malignancy or pts who, at the Investigator's discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment.
  • Serious psychiatric or medical conditions that could interfere with treatment
  • Significant neuropathy (Grade 3, Grade 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 (e.g. lansoprazole), enteric-coated aspirin or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
  • Pts in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g. due to pre-existing pulmonary, cardiac, or renal impairment
  • Pts with primary systemic amyloidosis
  • Pts who have received prior treatment with carfilzomib (Phase II only)
  • Pts who have received prior treatment with pomalidomide (Phase II only)
  • Pts who have received prior treatment with both carfilzomib \& pomalidomide (Phase I only)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • The John Theurer Cancer Center @ Hackensack UMC

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Columbia University

    New York, New York, 10032

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19105

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Multi-Center Phase I/II, Open-Label, Dose-Finding Pilot Study of the Combination of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to evaluate efficacy.

Read the detailed description

This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to evaluate efficacy. The study will explore the efficacy of CPD including overall response, time to progression, progression free survival, and time to next therapy.

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

    Also called PR-171

    IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days

  • PomalidomideDrug

    Also called CC-4047

    PO daily on Days 1-21, every 28 Days

  • DexamethasoneDrug

    Also called Decadron

    40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.

Study groups in NCT01464034
Study groupRoleWhat they receive
Carfilzomib, Pomalidomide, DexamethasoneExperimentalAll eligible subjects will receive the study intervention of Carfilzomib, Pomalidomide, and Dexamethasone.
Receives: Drug: Carfilzomib; Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

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

  1. Adverse Events as a Measure of Safety and Tolerability

    Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.

    Measured: Throughout treatment, estimated at 2-12 months per patient

  2. Overall Response in Phase II

    Overall Response (SD, MR, PR, VGPR, CR, sCR)

    Measured: Every 28 days while on treatment (estimated at 2- 12 months per patient)

Secondary outcomes (4)

  1. Overall Response in Phase I

    Overall response (SD, MR, PR, VGPR, CR, sCR)

    Measured: Every 28 days while on treatment (estimated at 2- 12 months per patient)

  2. Time to Progression

    Measured: Every 28 days while on treatment (estimated at 2-12 months per patient)

  3. Progression Free Survival

    Measured: throughout follow up (every 2-3 months for 2 years)

  4. Time to next therapy

    Measured: throughout follow up (every 2-3 months for 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 posted3 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJul 2020
  4. Study completionJul 2020

Why it stopped: Lack of enrollment

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
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01464034
Sponsor's protocol ID
AMyC 10-MM-01
Other IDs
IST-CAR-521, PO-MM-PI-0034
Status last verified
Jul 2022
First submitted
19 Oct 2011
Last updated
1 Aug 2022
Results posted
No
Data monitoring committee
No

Publications

  • Shah JJ, Stadtmauer EA, Abonour R, Cohen AD, Bensinger WI, Gasparetto C, Kaufman JL, Lentzsch S, Vogl DT, Gomes CL, Pascucci N, Smith DD, Orlowski RZ, Durie BG. Carfilzomib, pomalidomide, and dexamethasone for relapsed or refractory myeloma. Blood. 2015 Nov 12;126(20):2284-90. doi: 10.1182/blood-2015-05-643320. Epub 2015 Sep 17.

    PubMed 26384354

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Carfilzomib, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Criterium, Inc. at 9 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 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: stopped early, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.

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?

Adverse Events as a Measure of Safety and Tolerability (time frame: Throughout treatment, estimated at 2-12 months per patient). The study lists 2 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 NCT01464034, 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 1 Aug 2022.

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