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Recurrent Multiple MyelomaPhase 2NCT04883242

Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing Carfilzomib, Dexamethasone and Isatuximab in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by University of Washington at 1 site 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

This phase II trial studies the effect of isatuximab, carfilzomib, pomalidomide, and dexamethasone in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carfilzomib, Dexamethasone and Isatuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
29 Jul 2021to 31 Dec 2031
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with relapsed or refractory multiple myeloma, with >= 1 prior therapy
  • Must have received prior lenalidomide therapy
  • Must have measurable disease, as defined by International Myeloma Working Group criteria, having one or more of the following:
  • Serum M protein >= 0.5 g/dL
  • Urine M protein >= 200 mg/24 hours
  • Involved serum free light chain level >= 10 mg/dL with abnormal kappa/lambda ratio
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  • Measurable biopsy-proven plasmacytomas (>= 1 lesion has a single diameter >= 2 cm)
  • Bone marrow plasma cells >= 30%
  • Age 18 years and older, and have the capacity to give informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Subjects should have resolution of any toxicities from prior therapy to grade =< 1 or baseline prior to enrollment (with the exception of peripheral neuropathy)
  • Subjects are required to have grade =< 2 peripheral neuropathy to enroll
  • Prior autologous stem cell transplant is allowed; patients must be >= 6 months post- autologous stem cell transplantation to enroll
  • Estimated glomerular filtration rate (eGFR) >= 20 ml/min
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
  • Total bilirubin =< 2 x ULN
  • Absolute neutrophil count (ANC) >= 1,000/uL
  • Platelets >= 50,000/uL
  • Hemoglobin >= 8 g/dL
  • Growth factor use or transfusions may be used to meet the eligibility requirement for ANC, platelets, and hemoglobin
  • Female patients of childbearing potential and male patients must agree to use 2 effective forms of contraception or continuously abstain from heterosexual intercourse during the period of therapy, and for 6 months after discontinuation of study treatment for females and 3 months after discontinuation of study treatment for males

Who cannot join

  • History of clinically significant cardiovascular disease, including congestive heart failure New York Heart Association (NYHA) class 3-4, symptomatic ischemia, left ventricular ejection fraction < 40%, uncontrolled conduction abnormalities, myocardial infarction in last 6 months
  • Uncontrolled hypertension as determined by the principal investigator (PI) or designee
  • Active plasma cell leukemia or systemic amyloid light-chain (AL) amyloidosis
  • History of another primary malignancy that has not been in remission for at least 1 year
  • However, the following diagnoses are eligible for inclusion: non-melanoma skin cancer, localized prostate cancer, superficial bladder cancer, cervical carcinoma in situ, on biopsy or any prior malignancy with an estimated > 90% 1-year cure rate per sponsor-investigator
  • For patients with chronic hepatitis B viral infection, the hepatitis B virus (HBV) polymerase chain reaction (PCR) must be undetectable on suppressive therapy
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  • Patients with a history of Hepatitis C viral infection must have been treated and cured. For patients on treatment for hepatitis C, they are eligible if they have an undetectable hepatitis C virus (HCV) viral load
  • Subjects with active uncontrolled infection
  • Concurrent use of other anticancer agents or experimental treatments

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Isa-CAPED MM: Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone (Isa-KPd) for Patients With Relapsed/Refractory Multiple Myeloma

This phase II trial studies the effect of isatuximab, carfilzomib, pomalidomide, and dexamethasone in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Isatuximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Carfilzomib may stop the growth of cancer cells by blocking some of the proteins needed for cell growth. Pomalidomide may help shrink or slow the growth of multiple myeloma. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving isatuximab, carfilzomib, pomalidomide, and dexamethasone may kill more cancer cells.

Read the detailed description

OUTLINE:

INDUCTION: Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of subsequent cycles carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide orally (PO) once daily (QD) on days 1-21, and dexamethasone PO or IV on days 1,8, 15, and 22. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive isatuximab IV days 1 and 15, carfilzomib IV over 30 minutes on days 1 and 15, pomalidomide PO QD on days 1-21, and dexamethasone PO or IV on days 1, 8, 15, and 22. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

All patients undergo bone marrow aspirate and biopsy during screening, skeletal x-ray, computed tomography (CT), positron emission tomography (PET)-CT, or magnetic resonance imaging (MRI), bone marrow and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30 days, then for up to 5 years.

Being tested
Carfilzomib, Dexamethasone, Isatuximab, Pomalidomide, Bone Marrow Biopsy
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 Kyprolis, PR-171, Carfilnat, CFZ

    Given IV

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO or IV

  • IsatuximabBiological

    Also called Hu 38SB19, Isatuximab-irfc, SAR 650984, SAR650984

    Given IV

  • PomalidomideDrug

    Also called 4-Aminothalidomide, Actimid, CC-4047, Imnovid

    Given PO

  • Bone Marrow BiopsyProcedure or surgery

    Undergo bone marrow biopsy

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Skeletal Survey X-RayProcedure or surgery

    Undergo skeletal x-ray

  • Computed TomographyProcedure or surgery

    Also called CAT Scan, Computed Axial Tomography

    Undergo CT

  • Positron Emission TomographyProcedure or surgery

    Also called PET scan

    Undergo PET-CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI

    Undergo MRI

Study groups in NCT04883242
Study groupRoleWhat they receive
Treatment (isatuximab, carfilzomib, pomalidomide, steroid)ExperimentalINDUCTION: Patients receive isatuximab IV on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of subsequent cycles carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO QD on days 1-21, and dexamethasone PO or IV on days 1,8, 15, and 22. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive isatuximab IV days 1 and 15, carfilzomib IV over 30 minutes on days 1 and 15, pomalidomide PO QD on days 1-21, and dexamethasone PO or IV on days 1, 8, 15, and 22. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity. All patients undergo bone marrow aspirate and biopsy during screening, skeletal x-ray, CT, PET-CT, or MRI, bone marrow and blood sample collection throughout the study.
Receives: Drug: Carfilzomib; Drug: Dexamethasone; Biological: Isatuximab; Drug: Pomalidomide; Procedure: Bone Marrow Biopsy; Procedure: Bone Marrow Aspiration; Procedure: Skeletal Survey X-Ray; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging

What is being measured

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

  1. Overall response rate

    Responses will be based on the International Myeloma Working Group criteria for response in multiple myeloma.

    Measured: Up to 5 years post treatment

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    PFS will be calculated using assessments by investigators. Kaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).

    Measured: From first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years

  2. Overall survival

    Kaplan-Meier methodology will be used to estimate the event-free curves.

    Measured: From the first study drug administration to death from any cause, assessed up to 5 years

  3. Duration of response

    Measured: Up to 5 years post treatment

  4. Time to progression

    Measured: Up to 5 years post treatment

  5. Incidence of adverse events

    Will be measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 30 days post treatment

  6. Rates of minimal residual disease negativity

    Measured by next-generation sequencing of immunoglobulin genes in the bone marrow.

    Measured: Up to 5 years post treatment

Timeline

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

  1. First posted12 May 2021
  2. Study start29 Jul 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2031 (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
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04883242
Sponsor's protocol ID
RG1121154
Other IDs
NCI-2021-03406, 10690
Status last verified
Sep 2026
First submitted
6 May 2021
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carfilzomib, Dexamethasone and Isatuximab in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by University of Washington at 1 site 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 21 inclusion and 9 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Overall response rate (time frame: Up to 5 years post treatment). 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 NCT04883242.

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 16 Sep 2026.

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