AzTrials
AzTrials

Relapsed/Refractory Multiple MyelomaPhase 1/2NCT04635735

Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing Ipilimumab in people with Relapsed/Refractory Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Terminated

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

Official record
Search all trials

Trial summary

This study will test the safety of ipilimumab to see what effects, if any, the drug has when used as maintenance therapy for people with relapsed/refractory multiple myeloma who have received chemotherapy and allogeneic hematopoietic stem cell transplant (AHCT). Read more about this study

Who is it for?
Ages 21 to 73 years
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
7 sitesUnited States
Study dates
12 Jan 2020to 2 Feb 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 73 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion Criteria prior to Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT):
  • Willing and able to participate as a research subject and provide informed consent (Note: an LAR may sign the consent form on the partipant's behalf)
  • Diagnosis of relapsed refractory multiple myeloma defined as more than 2 lines of prior therapy with at least a very good partial remission to most recent salvage therapy.
  • Patients should have R-ISS stage II or III disease at diagnosis or high risk cytogenetics by IMWG criteria (t(4;14), del(17/17p), t(14;16), t(14;20), nonhyperdiploidy, and gain(1q)) at any time since diagnosis
  • Note:. A line of therapy is treatment between diagnosis and progression or between two progressions
  • Eligible for CD34-selected HSCT according to MSKCC adult BMT guidelines.
Show all 22Show fewer
  • Have a 10/10 matched donor
  • Age ≥ 21, < 73 years.
  • Karnofsky (adult) Performance Status ≥ 70%.
  • Patients must have adequate organ function measured by:
  • Cardiac: LVEF at rest must be ≥ 50%
  • Hepatic:
  • < 3x ULN ALT
  • < 1.5 ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
  • Renal: serum creatinine <1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl > 40 ml/min (measured or calculated/estimated) with dose adjustment of Fludarabine for <70ml/min
  • Pulmonary: DLCO > 50% of predicted (corrected for hemoglobin).
  • Non progressive myeloma (partial response or better) as defined by International Myeloma Working Group (IMWG) criteria
  • Engraftment of all cell lines without transfusion dependence, defined as:
  • absolute neutrophil count > 1.0K/mcL x 3 consecutive days
  • platelets > 50K/mcLx 7 consecutive days without platelet transfusion
  • no platelet or RBC transfusions within the preceding 7 days
  • ≥ 80% donor chimerism in the bone marrow

Who cannot join

  • Exclusion Criteria prior to Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT):
  • Patients ineligible for therapy with ipilimumab, for example:.
  • Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone equivalents) or other immunosuppressive medications at enrollment. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis).
  • Female patients who are pregnant or breast-feeding.
  • Patients with plasma cell leukemia at the time of diagnosis.
Show all 14Show fewer
  • Patients who have undergone prior allogeneic hematopoietic stem cell transplantation.
  • Patients who have had a previous malignancy that is not in remission.
  • Active infection or treatment for infection (patients on Cytomegalovirus (CMV) therapy will be considered eligible; patients with CMV viremia by PCR or disease with end-organ involvement will not be eligible)
  • Active GVHD of any grade or prior grade 3-4 GVHD
  • Active immune suppression, defined as:
  • active use of calcineurin inhibitors, mycophenolate mofetil, or other immunomodulators
  • steroid dosing exceeding 10 mg/d prednisone or equivalent
  • Receiving immunomodulatory agents (ex. thalidomide, lenalidomide, pomalidomide)

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase I/II Trial of Ipilimumab After CD34-Selected Allogeneic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma

This study will test the safety of ipilimumab to see what effects, if any, the drug has when used as maintenance therapy for people with relapsed/refractory multiple myeloma who have received chemotherapy and allogeneic hematopoietic stem cell transplant (AHCT). The investigators also want to find out whether giving ipilimumab after chemotherapy and AHCT is a better way to control the multiple myeloma than chemotherapy and AHCT alone.

Being tested
Ipilimumab
Keywords
Ipilimumab, Stem Cell Transplantation, 20-329
Medical subject headings
Multiple Myeloma

What participants receive

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

  • IpilimumabDrug

    Ipilimumab 3 mg/kg every 3 weeks for 4 doses.

Study groups in NCT04635735
Study groupRoleWhat they receive
Ipilimumab After Stem Cell TransplantationExperimentalThe patient will be admitted to a single room on the Adult Transplantation Service and allogeneic CD34-selected PBSC or marrow transplantation performed as per MSKCC adult BMT guidelines. Patients will be evaluated at approximately day 100 (±2 weeks) after allo-HSCT.
Receives: Drug: Ipilimumab

What is being measured

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

  1. Phase I: Maximum Tolerated Dose of Ipilimumab

    A maximum of 12 patients will be accrued and DLTs will be assessed in these patients. If any DLT is observed in more than one of the six patient cohort, a lower dose of ipilimumab will be evaluated in a new six patient cohort.

    Measured: 1 year

  2. Phase II: Progression Free Survival (PFS)

    criteria of the International Myeloma Working Group

    Measured: 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 posted19 Nov 2020
  2. Study start12 Jan 2020
  3. Primary completion2 Feb 2023
  4. Study completion2 Feb 2023

Why it stopped: Lack of accrual

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
Model description
This is a phase I/II, single arm, open label trial.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04635735
Sponsor's protocol ID
20-329
Status last verified
Feb 2023
First submitted
13 Nov 2020
Last updated
23 Mar 2023
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ipilimumab in people with Relapsed/Refractory Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 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 14 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase I: Maximum Tolerated Dose of Ipilimumab (time frame: 1 year). 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 NCT04635735.

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 23 Mar 2023.

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