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Multiple MyelomaPhase 2NCT04230031

Phase II Study of Daratumumab Pre-Mobilization and Post-ASCT in Multiple Myeloma

A Phase 2 study testing Daratumumab in people with Multiple Myeloma, run by Wake Forest University Health Sciences at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will use the drug daratumumab in patients who did not achieve at least a very good partial response (VGPR) and are already planned to have an Autologous Stem Cell Transplant (ASCT). 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?
Daratumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
2 Jul 2021to Jan 2027
Phase
Phase 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

  • Subject must meet all of the following applicable inclusion criteria to participate in this study:
  • Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 28 days prior to day 1 of daratumumab.
  • Failure to achieve a VGPR or better per IMWG 2016 criteria following a three-drug induction regimen for newly diagnosed MM. Subjects must have achieved at least minimal response to induction therapy.
  • Measurable disease at time of diagnosis (collected within 42 days prior to initiation of initial induction therapy) defined as:
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  • Serum M-protein ≥ 0.5. g/dL OR
  • Urine M-protein ≥ 200 mg/24 h OR
  • Involved free light chain (FLC) level ≥ 10 mg/dL provided serum FLC ratio is abnormal
  • ASCT is planned for post-induction therapy.
  • Prior radiotherapy must be completed at least 14 days prior to day 1 of daratumumab and subject must have recovered from any radiation-induced toxicities.
  • Recovered from all reversible acute toxic effects of induction therapy (other than alopecia) to ≤Grade 1 or baseline.
  • Demonstrate adequate organ function within 28 days of day 1 of daratumumab as defined in the table below:
  • White Blood Cell (WBC) ≥ 2,000/mm3
  • Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 without growth factors for 1 week prior
  • Hemoglobin (Hgb) ≥ 8 g/dL
  • Platelet count ≥ 70,000/mm3 if bone marrow plasmacytosis of <50%; otherwise ≥ 50,000/mm3(*)
  • Serum creatinine OR Creatinine clearance ≤ 1.5 × upper limit of normal (ULN) OR ≥ 30 mL/min as measured by a 24-hour urine collection or estimated by the Cockcroft - Gault formula
  • Bilirubin ≤ 2 × ULN; < 3.0 for subjects with Gilbert's Syndrome
  • Aspartate aminotransferase (AST) ≤ 2.5× ULN
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN
  • Females of childbearing potential (FCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to day 1 of daratumumab. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).
  • FCBP must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of <1% per year when used consistently and correctly) from the time of informed consent until 90 days (3 months) after the last dose of daratumumab. Contraceptive methods with low user dependency are preferable but not required.
  • Male subjects who are sexually active with a FCBP must be willing to use condoms from the time of informed consent until 3 months after the last dose of daratumumab has been discontinued. The FCBP partner should also consider contraception recommendations (see inclusion #11).
  • As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study.

Who cannot join

  • Subjects meeting any of the criteria below may not participate in the study:
  • Active infection requiring systemic therapy (i.e., involving IV antibiotics)
  • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study, and any female subject must agree not to donate eggs during the study and for 3 months after the last dose of daratumumab).
  • Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, carcinoma of the prostate with a current PSA value of <0.5 ng/mL or other cancer for which the subject has completed treatment, been disease-free for at least five years, and is considered by Sponsor-Investigator to be at <30% risk of relapse, or on hormonal therapy for a history of either prostate cancer or breast cancer, provided that there has been no evidence of disease progression during the previous three years.
  • Non-secretory MM.
  • Active involvement of the central nervous system by MM.
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  • Prior cerebrovascular accident with persistent neurological deficit.
  • POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • Had major surgery within 2 weeks prior to day 1 of daratumumab.
  • Treatment with any investigational drug within 4 weeks prior to day 1 of daratumumab.
  • Uncontrolled clinically significant illness including, but not limited to, uncontrolled hypertension (as per the most updated Joint National Committee for the Management of Hypertension definitions), symptomatic congestive heart failure (as per New York Heart Association [NYHA] class III or IV [see Appendix C], uncontrolled angina pectoris, myocardial infarction within the past 6 months from consent, known or suspected amyloidosis, uncontrolled cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator, or any other condition (including laboratory abnormalities) that would, in the opinion of the Sponsor-Investigator, place the subject at unacceptable risk if he/she were to participate in the study.
  • Known allergies, hypersensitivity or intolerance to monoclonal antibodies or human proteins, daratumumab or its excipients.
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
  • Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
  • Is known to be seropositive for human immunodeficiency virus.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

Other trials in United States

About this study

Official title: LCI-HEM-MYE-PurD-001: Phase II Study of Daratumumab Pre-Mobilization and Post-Autologous Stem Cell Transplant in Patients With Multiple Myeloma and Sub-Optimal Response to Induction

This study will use the drug daratumumab in patients who did not achieve at least a very good partial response (VGPR) and are already planned to have an Autologous Stem Cell Transplant (ASCT). Daratumumab will be given before the stem cell collection to attempt to get rid of any multiple myeloma cells that may be present in the stem cell collection and after the ASCT to get rid of any multiple myeloma cells that may be remaining.

Read the detailed description

This is a single arm, two-stage, phase II study to evaluate the rate of ≥ Complete Response (CR) post-Autologous Stem Cell Transplant (ASCT) in Multiple Myeloma (MM) subjects who failed to achieve at least a Very Good Partial Response (VGPR) post initial induction therapy for newly diagnosed disease, and for whom an ASCT is planned. Subjects will be treated with four weekly doses of daratumumab before mobilization for Hematopoietic Progenitor Cells (HPC) collection, followed by high dose chemotherapy and ASCT and four weekly doses of daratumumab after ASCT. A two-stage design will be implemented. Twenty three (23) subjects will be enrolled in the first stage, and if at least 12 of the 23 subjects have at least a CR after ASCT, an additional 16 subjects will be enrolled in the second stage (a total of 39 subjects).

Being tested
Daratumumab
Medical subject headings
Multiple Myeloma

What participants receive

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

Study groups in NCT04230031
Study groupRoleWhat they receive
1: DaratumumabExperimentalPre-ASCT and Post-ASCT: Daratumumab
Receives: Drug: Daratumumab

What is being measured

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

  1. Complete Response (CR) Rate Post-ASCT

    CR or better will be determined for each subject as binary variables indicating whether or not best overall response post-ASCT is a CR or better as determined by the IMWG 2016 response criteria.

    Measured: up to 100 days post-ASCT

Secondary outcomes (8)

  1. VGPR+ Rate

    Post ASCT VGPR+ response will be determined for each subject as a binary variable indicating whether or not the subject achieved a post-ASCT response of VGPR or better as determined by the IMWG response criteria

    Measured: up to 100 days post-ASCT

  2. Time to First Response (TTFR)

    TTFR is defined as the time from start of induction therapy to the time when the first occurrence of a post-ASCT VGPR or better was achieved.

    Measured: up to 100 days post-ASCT

  3. Time to Best Response (TTBR)

    TTBR is defined as the time from start of induction therapy to the time when the best response of VGPR or better was achieved.

    Measured: up to 100 days post-ASCT

  4. Duration of Response (DOR)

    DoR will be calculated separately for each subject achieving PR or better, VGPR or better, and CR or better. The DoR intervals will be calculated from the time of the first assessment that identified response until disease progression or death from any cause.

    Measured: up to 7 years

  5. Progression-Free Survival (PFS)

    PFS is defined as the duration of time from start of induction therapy to first occurrence of either progressive disease or death from any cause

    Measured: up to 7 years

  6. Time to Progression (TTP)

    TTP will be calculated in the same fashion as described for PFS with the exception that for subjects who die for causes other than disease progression.

    Measured: up to 7 years

  7. Time to Next Treatment (TTNT)

    TTNT will be calculated from start of induction therapy until the start of the first subsequent anti-cancer therapy after all protocol directed therapy is completed.

    Measured: up to 7 years

  8. Overall Survival (OS)

    OS is defined as the duration from start of induction therapy to the date of death from any cause.

    Measured: up to 7 years

Timeline

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

  1. First posted18 Jan 2020
  2. Study start2 Jul 2021
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Why it stopped: Difficult enrollment due to changes in standard of care

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04230031
Sponsor's protocol ID
LCI-HEM-MYE-PURD-001
Other IDs
00040671
Status last verified
Mar 2022
First submitted
13 Jan 2020
Last updated
21 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab in people with Multiple Myeloma, run by Wake Forest University Health Sciences 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 25 inclusion and 15 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 21 Apr 2022. 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?

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?

Complete Response (CR) Rate Post-ASCT (time frame: up to 100 days post-ASCT). 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 NCT04230031.

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 2022.

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