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Plasma Cell LeukemiaPhase 1NCT03591744

Daratumumab, Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin Hydrochloride, and Lenalidomide in Treating Participants With Plasma Cell Leukemia

A Phase 1 study testing Bortezomib, Daratumumab and Dexamethasone in people with Plasma Cell Leukemia, run by City of Hope Medical Center at 5 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial studies side effects of daratumumab, bortezomib, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide in treating participants with plasma cell leukemia. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plasma Cell Leukemia
What is being tested?
Bortezomib, Daratumumab and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
5 sitesUnited States
Study dates
18 Sep 2018to 19 Sep 2019
Phase
Phase 1
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

  • Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines.
  • Willingness to provide bone marrow and peripheral blood samples for research purposes. If unavailable, exceptions may be granted with study principal investigator (PI) approval.
  • All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) program and be willing to comply with its requirements.
  • Karnofsky performance status (KPS) > 60.
  • Plasma cell leukemia; either newly diagnosed or relapsed: defined as the presence of > 2 x 10^9/L peripheral blood plasma cells or plasmacytosis accounting for > 20% of the differential white cell count.
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Absolute neutrophil count (ANC) >= 500/mm^3
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  • NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary ot disease involvement.
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Total bilirubin =< 2.0 x ULN (unless has Gilbert's disease).
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Aspartate aminotransferase (AST) =< 3.0 x ULN.
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Alanine aminotransferase (ALT) =< 3.0 x ULN.
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Creatinine clearance of >= 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula.
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Left ventricular ejection fraction (LVEF) > 45%
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Hemoglobin >= 8.0 g/dL
  • Note: Transfusion support is allowed.
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Seronegative for human immunodeficiency virus (HIV) antigen-antibody (Ag/Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (RPR).
  • If positive, hepatitis C RNA quantitation must be performed.
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Meets other institutional and federal requirements for infectious disease titer requirements.
  • Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy.
  • Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy.
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only).
  • Women of childbearing potential must follow pregnancy testing requirements as outline in REMS program material.

Who cannot join

  • Progression or intolerance to daratumumab, bortezomib, or lenalidomide.
  • Prior stem cell transplant.
  • Participant is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment.
  • Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable.
  • Vaccination with live attenuated vaccines within 4 weeks of first study agent administration.
  • Participant is currently using or has used immunosuppressive medication within 14 days prior to the first study dose of study treatment. The following are exceptions:
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  • Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)
  • Chronic systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., infusion-related reactions, computed tomography [CT] scan premedication).
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
  • Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal.
  • Has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification.
  • Clinically significant uncontrolled illness.
  • Active infection requiring intravenous antibiotics or antifungals within 14 days prior to start of study treatment.
  • Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection.
  • Grade >= 3 peripheral neuropathy, or grade >= 2 with pain on clinical examination during the screening period.
  • Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months. Note: Prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant.
  • Other active malignancy. Exceptions: Non-melanoma skin cancer, ductal breast carcinoma in situ (DCIS) or carcinoma-in-situ of the cervix. Note: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer. Prior malignancy treated with curative intent is not an exclusion.
  • Females only: Pregnant or breastfeeding.
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • City of Hope Medical Center

    Duarte, California, 91010

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Siteman Cancer Center at Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase 1 Study of Daratumumab When Given in Combination With Bortezomib, Dexamethasone, Doxil, and Lenalidomide in Patients With Plasma Cell Leukemia

This phase I trial studies side effects of daratumumab, bortezomib, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide in treating participants with plasma cell leukemia. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab, bortezomib, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide in treating participants with plasma cell leukemia.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose(s) (MTD)/recommended phase 2 dose(s) (RP2D) of, bortezomib and pegylated liposomal doxorubicin hydrochloride (doxil) when given in combination with fixed dose daratumumab, lenalidomide, and dexamethasone.

SECONDARY OBJECTIVES:

  1. To assess the tolerability and safety of the planned regimen, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration.

II. To estimate and assess overall response rate, response duration, and survival probabilities (overall and progression-free).

EXPLORATORY OBJECTIVES:

  1. Quantify CD38+ cells from the peripheral blood mononuclear cells (PBMC) fraction, including T, natural killer (NK), and monocytic subsets.

II. Assess possible changes in CD38 expression, as well as the co-receptor marker CD31, overall and by response status (responder/non-responder).

III. Assess cytokine levels in peripheral blood plasma. IV. Quantify CD38+ cells from the bone marrow CD-138 negative fractions and acellular fractions, including T, NK, and monocytic subsets.

  1. Assess possible changes in CD38 expression, as well as the co-receptor marker CD31, overall and by response status (responder/non-responder).

VI. Assess cytokine levels in the bone marrow acellular fraction. VII. Investigate CD38 cellular localization in plasma cells and extracellular vesicles from blood plasma.

VIII. Assess messenger ribonucleic acid (mRNA) expression in the peripheral blood mononuclear cell (PBMC), the bone marrow CD138-negative fraction, the T cell fraction, and plasma cells.

IX. Investigate epigenetic changes in CD38 mRNA expression.

OUTLINE:

Participants receive daratumumab intravenously (IV) on days 1, 8, 15, and 22, dexamethasone IV/orally (PO) on days 1, 2, 8, 9, 15, 16, 22, and 23, pegylated liposomal doxorubicin hydrochloride IV on day 8, lenalidomide PO daily on days 1-14, and bortezomib subcutaneously (SC) on days 1, 4, 8, and 11 of courses 1 and 2. Participants then receive daratumumab IV on days 1, and 15, dexamethasone IV/PO on days 1, 2, 8, 9, 15, 16, 22, and 23, pegylated liposomal doxorubicin hydrochloride IV on day 8, lenalidomide PO daily on days 1-14, and bortezomib SC on days 1, 4, 8, and 11 of courses 3 and 4. Courses repeat every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants may receive up to 8 courses at the discretion of treating physician.

After completion of study treatment, participants are followed up at 30 days and then every 3 months for 18 months.

Being tested
Bortezomib, Daratumumab, Dexamethasone, Lenalidomide, Pegylated Liposomal Doxorubicin Hydrochloride
Medical subject headings
Leukemia, Plasma Cell

What participants receive

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

  • BortezomibDrug

    Also called [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341

    Given SC

  • DaratumumabBiological

    Also called Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414

    Given IV

  • DexamethasoneDrug

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

    Given IV and PO

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

  • Pegylated Liposomal Doxorubicin HydrochlorideDrug

    Also called ATI-0918, Caelyx, DOX-SL, Doxil

    Given IV

Study groups in NCT03591744
Study groupRoleWhat they receive
Treatment (daratumumab, bortezomib, chemotherapy)ExperimentalParticipants receive daratumumab IV on days 1, 8, 15, and 22, dexamethasone IV/PO on days 1, 2, 8, 9, 15, 16, 22, and 23, pegylated liposomal doxorubicin hydrochloride IV on day 8, lenalidomide PO daily on days 1-14, and bortezomib SC on days 1, 4, 8, and 11 of courses 1 and 2. Participants then receive daratumumab IV on days 1, and 15, dexamethasone IV/PO on days 1, 2, 8, 9, 15, 16, 22, and 23, pegylated liposomal doxorubicin hydrochloride IV on day 8, lenalidomide PO daily on days 1-14, and bortezomib SC on days 1, 4, 8, and 11 of courses 3 and 4. Courses repeat every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants may receive up to 8 courses at the discretion of treating physician.
Receives: Drug: Bortezomib; Biological: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Pegylated Liposomal Doxorubicin Hydrochloride

What is being measured

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

  1. Incidence of adverse events assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Observed toxicities will be tabulated using frequencies and percentages based on the CTCAE v5.0.

    Measured: Up to 30 days

Secondary outcomes (4)

  1. Overall response rate described by the International Myeloma Working Group (IMWG)

    Response rates will also be evaluated based on number and type of prior therapy(ies); the exact binomial confidence interval (CI) will be calculated for these estimates.

    Measured: Up to 18 months

  2. Duration of response

    The overall response rate (ORR) will be estimated by the number of participants who achieve a confirmed response (stringent complete response [sCR]/complete response [CR]/very good partial response [VGPR] or partial response [PR]) divided by the total number of response evaluable participants. Response rates will also be evaluated based on number and type of prior therapy(ies); the exact binomial CI will be calculated for these estimates.

    Measured: Up to 18 months

  3. Overall survival rate

    Will be estimated using the product-limit method of Kaplan and Meier; 95% confidence intervals will be calculated using Greenwood's formula.

    Measured: From date of first dose of study drug to date of death from any cause, assessed up to 18 months

  4. Progression-free survival rate

    Will be estimated using the product-limit method of Kaplan and Meier; 95% confidence intervals will be calculated using Greenwood's formula.

    Measured: From date of first dose of study drug to date of first documented disease relapse, progression or death from any cause, whichever occurs first, up to 18 months

Timeline

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

  1. First posted19 Jul 2018
  2. Study start18 Sep 2018 (estimated)
  3. Primary completion19 Sep 2019
  4. Study completion19 Sep 2019

Why it stopped: Budgetary constraints

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03591744
Sponsor's protocol ID
18162
Other IDs
NCI-2018-01405, 18162
Status last verified
Oct 2026
First submitted
9 Jul 2018
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bortezomib, Daratumumab and Dexamethasone in people with Plasma Cell Leukemia, run by City of Hope Medical Center at 5 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 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: withdrawn, as of the sponsor's last update on 22 Oct 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. 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 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.

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 withdrawn before enrolling participants, so there are no results.

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?

Incidence of adverse events assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (time frame: Up to 30 days). 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 NCT03591744.

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 Oct 2026.

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