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Multiple Myeloma, RefractoryPhase 1/2NCT05493618

Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma.

A Phase 1/2 study testing Pembrolizumab, Belantamab mafodotin and Dexamethasone in people with Multiple Myeloma, Refractory, run by Hackensack Meridian Health at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a single arm, multi-institution (1) Hackensack Meridian Health at Hackensack, New Jersey (NJ) (2) Jersey Shore Medical Center, Neptune, NJ and (3) Georgetown/Lombardi Cancer Center) phase II study of the combination of pembrolizumab, belantamab, and dexamethasone in patients with triple class refractory… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Refractory
What is being tested?
Pembrolizumab, Belantamab mafodotin 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
3 sitesUnited States
Study dates
Dec 2022to Nov 2025
Phase
Phase 1/2
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

  • Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  • Any of the following laboratory abnormalities (unless there is >50% plasma cell involvement of the bone marrow):
  • Absolute neutrophil count (ANC) < 1,000/μL
  • Platelet count < 30,000/μL
  • Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
  • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≥ 2.5 x upper limit of normal (ULN)
Show all 37Show fewer
  • Serum total bilirubin, direct bilirubin, and alkaline phosphatase ≥ 1.5 x ULNf. Subjects with serious renal impairment ([CrCl] < 50 mL/min) or requiring dialysis would be excluded
  • International Normalized Ratio (INR) of >1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Subjects with a prior history of malignancies, other than Multiple Myeloma (MM), unless the subject has been free of the disease for ≥ 5 years with the exception of the following noninvasive malignancies:
  • Basal cell carcinoma of the skin
  • Squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Incidental histological findings of prostate cancer such as T1a or T1b using the Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer that is curative
  • Subject has received a prior anti-BCMA therapy
  • Subject has received prior systemic anti-cancer therapy including investigational agents within 3 weeks prior to study intervention
  • Subject has received prior radiotherapy within 2 weeks of start of study intervention.
  • Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
  • Subject has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks prior to the first dose of study intervention
  • Subject has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Subject has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis.
  • Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 3 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  • Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Subject 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Subject has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Subject has an active infection requiring systemic therapy.
  • Subject has a known history of Human Immunodeficiency Virus (HIV) infection.
  • Note: No HIV testing is required unless mandated by local health authority.
  • Subject has active Hepatitis B infection or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis C is required unless mandated by local health authority.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 4 months after the last dose of trial treatment.
  • Subject has had an allogenic tissue/solid organ transplant
  • Subject has uncontrolled ocular disease or keratopathy
  • Subject has uncontrolled cardiovascular disease, specifically uncontrolled hypertension, recent Myocardial Infarction (within 4 months), NYHA Stage 3 or 4 congestive heart failure.
  • Subject is a WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose of study intervention (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Contraindications to the other treatment regimens, as per local prescribing information
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. -

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • John Theurer Cancer Center, Hackensack Meridian Health

    Hackensack, New Jersey, 07410

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • Lombardi Comprehensive Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase II Study of Pembrolizumab, Belantamab and Dexamethasone in Patients With Triple Class Refractory Multiple Myeloma.

This is a single arm, multi-institution (1) Hackensack Meridian Health at Hackensack, New Jersey (NJ) (2) Jersey Shore Medical Center, Neptune, NJ and (3) Georgetown/Lombardi Cancer Center) phase II study of the combination of pembrolizumab, belantamab, and dexamethasone in patients with triple class refractory multiple myeloma.

Read the detailed description

This is a single arm, multi-institution (1) Hackensack Meridian Health at Hackensack, NJ (2) Jersey Shore Medical Center, Neptune, NJ and (3) Georgetown/Lombardi Cancer Center) phase II study of the combination of pembrolizumab, belantamab, and dexamethasone in patients with triple class refractory multiple myeloma. All institutions will share the same Institutional Review Board.

Safety lead-in Cohort: After the first 10 patients are enrolled, an independent safety review committee will meet to review adverse events and toxicity and determine whether the trial will continue to enroll.

Phase 2 portion: The remainder of patients will be enrolled using a Simon's - 2 stage design.

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

Being tested
Pembrolizumab, Belantamab mafodotin, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

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

  • PembrolizumabDrug

    Also called Keytruda

    Pembrolizumab 200 mg IV q3 weeks until unacceptable toxicity or disease progression for up to 2 years (35 cycles).

  • Belantamab mafodotinDrug

    Also called Blenrep

    Belantamab 2.5 mg/kg IV q3 weeks until unacceptable toxicity or disease progression for up to 2 years (35 cycles).

  • DexamethasoneDrug

    Also called Decadron

    Dexamethasone 40 mg IV q3 weeks (20 mg if patient >75) until unacceptable toxicity or disease progression for up to 2 years (35 cycles).

Study groups in NCT05493618
Study groupRoleWhat they receive
Single-arm, multi-institutionExperimentalStudy Arm: Pembrolizumab 200 mg IV q3 weeks Belantamab 2.5 mg/kg IV q3 weeks. Dex 40 mg IV q3 weeks (20 mg if patient >75) Treatment will be administered on a 21-day cycle and will be continued until unacceptable toxicity or disease progression for up to 2 years (35 cycles)
Receives: Drug: Pembrolizumab; Drug: Belantamab mafodotin; Drug: Dexamethasone

What is being measured

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

  1. Overall Response Rate (ORR)

    To evaluate the overall response rate for pembrolizumab, belantamab and dexamethasone (PBd) in patients with triple class refractory multiple myeloma.

    Measured: 2 years

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    To assess rates of progression-free survival (PFS)

    Measured: 2 years

  2. Overall Survival (OS)

    To assess rates of overall survival (OS)

    Measured: 2 years

  3. Time to next treatment

    To assess rates of time to next treatment

    Measured: 2 years

  4. Tolerability and Safety

    To determine the tolerability and safety of the combination of pembrolizumab with belantamab and dexamethasone by rate of incidence of adverse events using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE), v5.0

    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 posted9 Aug 2022
  2. Study startDec 2022 (estimated)
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Why it stopped: Study Drug Unavailability

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
Sequential
Model description
Safety lead-in Cohort: After the first 10 patients are enrolled, an independent safety review committee will meet to review adverse events and toxicity and determine whether the trial will continue to enroll. Phase 2 portion: The remainder of patients will be enrolled using a Simon's - 2 stage design.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05493618
Sponsor's protocol ID
Pro2022-0093
Other IDs
ISS 60989
Status last verified
Jan 2023
First submitted
5 Aug 2022
Last updated
27 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Disis ML. Immune regulation of cancer. J Clin Oncol. 2010 Oct 10;28(29):4531-8. doi: 10.1200/JCO.2009.27.2146. Epub 2010 Jun 1.

    PubMed 20516428

  • Dudley ME, Wunderlich JR, Yang JC, Sherry RM, Topalian SL, Restifo NP, Royal RE, Kammula U, White DE, Mavroukakis SA, Rogers LJ, Gracia GJ, Jones SA, Mangiameli DP, Pelletier MM, Gea-Banacloche J, Robinson MR, Berman DM, Filie AC, Abati A, Rosenberg SA. Adoptive cell transfer therapy following non-myeloablative but lymphodepleting chemotherapy for the treatment of patients with refractory metastatic melanoma. J Clin Oncol. 2005 Apr 1;23(10):2346-57. doi: 10.1200/JCO.2005.00.240.

    PubMed 15800326

  • Hunder NN, Wallen H, Cao J, Hendricks DW, Reilly JZ, Rodmyre R, Jungbluth A, Gnjatic S, Thompson JA, Yee C. Treatment of metastatic melanoma with autologous CD4+ T cells against NY-ESO-1. N Engl J Med. 2008 Jun 19;358(25):2698-703. doi: 10.1056/NEJMoa0800251.

    PubMed 18565862

  • Greenwald RJ, Freeman GJ, Sharpe AH. The B7 family revisited. Annu Rev Immunol. 2005;23:515-48. doi: 10.1146/annurev.immunol.23.021704.115611.

    PubMed 15771580

  • Okazaki T, Maeda A, Nishimura H, Kurosaki T, Honjo T. PD-1 immunoreceptor inhibits B cell receptor-mediated signaling by recruiting src homology 2-domain-containing tyrosine phosphatase 2 to phosphotyrosine. Proc Natl Acad Sci U S A. 2001 Nov 20;98(24):13866-71. doi: 10.1073/pnas.231486598. Epub 2001 Nov 6.

    PubMed 11698646

  • Zhang X, Schwartz JC, Guo X, Bhatia S, Cao E, Lorenz M, Cammer M, Chen L, Zhang ZY, Edidin MA, Nathenson SG, Almo SC. Structural and functional analysis of the costimulatory receptor programmed death-1. Immunity. 2004 Mar;20(3):337-47. doi: 10.1016/s1074-7613(04)00051-2.

    PubMed 15030777

  • Chemnitz JM, Parry RV, Nichols KE, June CH, Riley JL. SHP-1 and SHP-2 associate with immunoreceptor tyrosine-based switch motif of programmed death 1 upon primary human T cell stimulation, but only receptor ligation prevents T cell activation. J Immunol. 2004 Jul 15;173(2):945-54. doi: 10.4049/jimmunol.173.2.945.

    PubMed 15240681

  • Sheppard KA, Fitz LJ, Lee JM, Benander C, George JA, Wooters J, Qiu Y, Jussif JM, Carter LL, Wood CR, Chaudhary D. PD-1 inhibits T-cell receptor induced phosphorylation of the ZAP70/CD3zeta signalosome and downstream signaling to PKCtheta. FEBS Lett. 2004 Sep 10;574(1-3):37-41. doi: 10.1016/j.febslet.2004.07.083.

    PubMed 15358536

  • Riley JL. PD-1 signaling in primary T cells. Immunol Rev. 2009 May;229(1):114-25. doi: 10.1111/j.1600-065X.2009.00767.x.

    PubMed 19426218

  • Parry RV, Chemnitz JM, Frauwirth KA, Lanfranco AR, Braunstein I, Kobayashi SV, Linsley PS, Thompson CB, Riley JL. CTLA-4 and PD-1 receptors inhibit T-cell activation by distinct mechanisms. Mol Cell Biol. 2005 Nov;25(21):9543-53. doi: 10.1128/MCB.25.21.9543-9553.2005.

    PubMed 16227604

  • Francisco LM, Sage PT, Sharpe AH. The PD-1 pathway in tolerance and autoimmunity. Immunol Rev. 2010 Jul;236:219-42. doi: 10.1111/j.1600-065X.2010.00923.x.

    PubMed 20636820

  • Yu B, Jiang T, Liu D. BCMA-targeted immunotherapy for multiple myeloma. J Hematol Oncol. 2020 Sep 17;13(1):125. doi: 10.1186/s13045-020-00962-7.

    PubMed 32943087

  • Raje N, Berdeja J, Lin Y, Siegel D, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Turka A, Lam LP, Morgan RA, Friedman K, Massaro M, Wang J, Russotti G, Yang Z, Campbell T, Hege K, Petrocca F, Quigley MT, Munshi N, Kochenderfer JN. Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2019 May 2;380(18):1726-1737. doi: 10.1056/NEJMoa1817226.

    PubMed 31042825

  • Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortum KM, Rodriguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.

    PubMed 31859245

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab, Belantamab mafodotin and Dexamethasone in people with Multiple Myeloma, Refractory, run by Hackensack Meridian Health at 3 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 0 inclusion and 37 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 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

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?

Overall Response Rate (ORR) (time frame: 2 years). 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 NCT05493618, which also lists 14 linked publications.

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 27 Jan 2023.

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