AzTrials
AzTrials

Multiple MyelomaPhase 2NCT04361851

Study of Dara-Pembro for Multiple Myeloma Patients

A Phase 2 study testing Pembrolizumab in people with Multiple Myeloma, run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a phase II, single-arm, open-label study in subjects with relapsed and/or refractory multiple myeloma (RRMM) comparing Pembrolizumab (Pembro) in combination with Daratumumab (Dara) to the historical control of Daratumumab. 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?
Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
9 Jun 2021to May 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

None listed.

Who cannot join

  • Subjects with active infection requiring systemic therapy such as known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) or HIV. (NOTE: at discretion of investigator, subjects with uncomplicated urinary tract infections may be eligible.)
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of trial participation, starting with consent through 120 days after the last dose of pembrolizumab and 3 months of last dose of daratumumab (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
  • Autologous stem cell transplantation within 12 weeks of cycle 1, day 1
  • History of previous or concurrent malignancy other than MM within the past 2 years. Exceptions include basal cell or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Known history of interstitial lung disease, known history of non-infectious pneumonitis that required steroids, current pneumonitis, known chronic obstructive pulmonary disease (COPD) with FEV1 ≤ 30% of predicted normal, known moderate or severe persistent asthma within the past 2 years, SpO2 ≤ 90%.
Show all 21Show fewer
  • Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), with any neurologic symptoms resolved or stabilized without requirement of steroid treatment for at least 14 days prior to cycle 1, day 1.
  • Clinically significant cardiac disease including myocardial infarction within 6 months before cycle 1 day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g. unstable angina, congestive heart failure NYHA class III-IV), clinically significant cardiac arrhythmia (NCI CTCAE grade ≥ 2).
  • Grade 2 peripheral neuropathy with associated pain or grade ≥3 peripheral neuropathy regardless of the presence of pain.
  • Plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or amyloidosis.
  • Major surgery within 2 weeks before Cycle 1, Day 1. Subjects with prior surgery must be expected to have fully recovered from surgery during the time the subject is expected to receive treatment on study.
  • Prior exposure to an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 agent.
  • Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
  • History of solid organ transplantation.
  • History of allogeneic stem cell transplantation.
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of cycle 1, day 1.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to Cycle 1, Day 1.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

About this study

Official title: LCI-HEM-DRMM-DPEM-001: Phase II Study of Daratumumab-Pembrolizumab for Multiple Myeloma Patients With ≥ Three Prior Lines of Therapy

This is a phase II, single-arm, open-label study in subjects with relapsed and/or refractory multiple myeloma (RRMM) comparing Pembrolizumab (Pembro) in combination with Daratumumab (Dara) to the historical control of Daratumumab.

Read the detailed description

Heavily pre-treated multiple myeloma patients who are treated with single agent daratumumab have been reported to have median PFS of 4 months. A median PFS of 4 months corresponds to an 8-month progression-free survival rate of 25% (based on the exponential survival distribution). For this population of patients treated with Daratumumab and Pembrolizumab, the aim is to improve the 8-month PFS rate to 50%. Thirty-three RRMM patients who have received ≥ 3 lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) will be eligible for enrollment. Sixteen (16) subjects will be enrolled in the first stage, and if at least 5 of the 16 patients are alive and progression free at 8 months, an additional 17 subjects will be enrolled.

Being tested
Pembrolizumab
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 NCT04361851
Study groupRoleWhat they receive
Single ArmExperimentalPembrolizumab and Daratumumab
Receives: Drug: Pembrolizumab

What is being measured

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

  1. 8-Month Progression-Free Survival (PFS8)

    PFS8 will be determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 8 months.

    Measured: 8 months

Secondary outcomes (9)

  1. Complete Response (CR) Rate

    CR will be determined for each subject as a binary variable indicating whether or not the specific level of response was achieved.

    Measured: up to 5 years

  2. Stringent Complete Response (sCR) Rate

    sCR will be determined for each subject as a binary variable indicating whether or not the specific level of response was achieved.

    Measured: up to 5 years

  3. Clinical Benefit Rate (CBR)

    CBR (achieving a minimal response or better) will be determined for each subject as a binary variable indicating whether or not the specific level of response was achieved.

    Measured: up to 5 years

  4. Overall Response Rate (ORR)

    ORR (achieving a PR or better) will be determined for each subject as a binary variable indicating whether or not the specific level of response was achieved.

    Measured: up to 5 years

  5. Time to First Response (TTFR)

    TTFR is defined as the time from the start of study treatment to the time when the first occurrence of a MR or better was achieved.

    Measured: up to 5 years

  6. Time to Best Response (TTBR)

    TTBR is defined as the time from the start of study treatment to the time when the best response of MR or better was achieved.

    Measured: up to 5 years

  7. Duration of Response (DOR)

    DoR will be calculated for those subjects who achieve a PR or better and is defined as the time first occurrence of PR (or better) until the time of disease progression or death.

    Measured: up to 5 years

  8. Progression-Free Survival (PFS)

    PFS is defined as the duration of time from the initiation of study treatment to first occurrence of either progressive disease or death.

    Measured: up to 5 years

  9. Overall Survival (OS)

    OS is defined as the duration from initiation of study treatment to the date of death from any cause.

    Measured: up to 5 years

Timeline

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

  1. First posted24 Apr 2020
  2. Study start9 Jun 2021
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Why it stopped: Low enrollment due to competing studies

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
NCT04361851
Sponsor's protocol ID
LCI-HEM-DRMM-DPEM-001
Other IDs
00043318
Status last verified
Jan 2022
First submitted
22 Apr 2020
Last updated
26 Apr 2022
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 2 study testing Pembrolizumab in people with Multiple Myeloma, run by Wake Forest University Health Sciences.

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 0 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

8-Month Progression-Free Survival (PFS8) (time frame: 8 months). 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 NCT04361851.

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 26 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in