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Multiple MyelomaPhase 1NCT04895410

Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma

A Phase 1 study testing Lemzoparlimab, Dexamethasone and Carfilzomib in people with Multiple Myeloma, run by AbbVie at 32 sites in 7 countries.

Terminated

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

Official record
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Trial summary

Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma… 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?
Lemzoparlimab, Dexamethasone and Carfilzomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
32 sitesin 7 countries
Study dates
17 Jan 2022to 24 Jun 2022
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

  • Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
  • Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
  • Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy.
  • Measurable disease per the protocol within 28 days prior to enrollment.
  • Arm A - Lemzoparlimab with or without Dexamethasone
  • For Both Escalation and Expansion Phase, participant must have refractory to 3 prior lines of treatment of anti-myeloma treatments, as outlined in the protocol.
Show all 13Show fewer
  • Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
  • For Escalation Phase - Participant must have received at least 3 prior lines of therapy, as outlined in the protocol.
  • For Expansion Phase- Participant must have received at least 2 prior line of therapy, as outlined in the protocol.
  • Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
  • For Escalation Phase- Participant must have received at least 3 prior lines of therapy as outlined in the protocol.
  • For Expansion Phase- Participant must have received at least 1 prior line of therapy.
  • Arm D - Lemzoparlimab + Daratumumab-Dexamethasone -- For Both Escalation and Expansion Phase - Participant must: --- Have received at least 3 prior lines of therapy, as outlined in the protocol.

Who cannot join

  • Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
  • For Both Escalation and Expansion Phase participant must have had no prior treatment with pomalidomide.
  • Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
  • For Both Escalation and Expansion Phase - prior treatment with carfilzomib.
  • Arm D - Lemzoparlimab + Daratumumab-Dexamethasone
  • For Both Escalation and Expansion Phase - prior treatment with daratumumab or other anti-CD38 therapy.

Trial locations and contacts

32 sites in 7 countries.

32 sites in 7 countries

United States12 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309

    Ann Arbor, Michigan, 48109

  • University of Virginia /ID# 229396

    Charlottesville, Virginia, 22908

  • Henry Ford Health System /ID# 230341

    Detroit, Michigan, 48202

  • Duke University Hospital /ID# 229564

    Durham, North Carolina, 27710

  • Norton Cancer Institute - St Matthews /ID# 229319

    Louisville, Kentucky, 40207

  • Sylvester Comprehensive Cancer Center /ID# 228817

    Miami, Florida, 33136-1002

  • Rutgers Cancer Institute of New Jersey /ID# 230174

    New Brunswick, New Jersey, 08901

  • Tulane Cancer Center Clinic /ID# 229832

    New Orleans, Louisiana, 70112

  • Columbia University Medical Center /ID# 229971

    New York, New York, 10032-3729

  • Perelman Center for Advanced Medicine - /ID# 228693

    Philadelphia, Pennsylvania, 19104-5127

  • Moffitt Cancer Center /ID# 229939

    Tampa, Florida, 33612-9416

  • Wake Forest Baptist Health /ID# 229996

    Winston-Salem, North Carolina, 27157-0001

Other trials in United States

Israel6 sites

  • Rambam Health Care Campus /ID# 229485

    Haifa, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 229477

    Jerusalem, 91120

  • Meir Medical Center /ID# 229480

    Kfar Saba, 4428164

  • Rabin Medical Center /ID# 229488

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 229483

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 229478

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Spain6 sites

  • Hospital Parc de Salut del Mar /ID# 229371

    Barcelona, 08003

  • Hospital Santa Creu i Sant Pau /ID# 229369

    Barcelona, 08041

  • Hospital Universitario Reina Sofia /ID# 229388

    Córdoba, 14004

  • Hospital Universitario 12 de Octubre /ID# 229355

    Madrid, 28041

  • Hospital Unversitario Marques de Valdecilla /ID# 229354

    Santander, Cantabria, 39008

  • Hospital Clínico Universitario de Santiago-CHUS /ID# 229356

    Santiago de Compostela, A Coruna, 15706

Other trials in Spain

France4 sites

  • Hopital Henri Mondor /ID# 228562

    Créteil, 94000

  • CHU de Nantes, Hotel Dieu -HME /ID# 228559

    Nantes, Pays de la Loire Region, 44000

  • HCL - Hôpital Lyon Sud /ID# 229834

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • CHU Poitiers - La milétrie /ID# 229833

    Poitiers, Poitou-Charentes, 86000

Other trials in France

Australia2 sites

  • Alfred Health /ID# 229347

    Melbourne, Victoria, 3004

  • The Queen Elizabeth Hospital /ID# 229345

    Woodville South, South Australia, 5011

Other trials in Australia

Germany1 site

  • Asklepios Klinik Altona /ID# 229143

    Hamburg, 22763

Other trials in Germany

Japan1 site

  • University Hospital Kyoto Prefectural University of Medicine /ID# 241833

    Kyoto, Kyoto, 602-8566

Other trials in Japan

About this study

Official title: A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-Myeloma Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed.

Lemzoparlimab is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab, followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide.

Read more

In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests and side effects.

Being tested
Lemzoparlimab, Dexamethasone, Carfilzomib, Pomalidomide, Daratumumab
Keywords
Lemzoparlimab, ABBV-IMAB-TJC4, Relapsed or refractory multiple myeloma (R/R MM), Cancer, TJ011133, Multiple Myeloma
Medical subject headings
Multiple Myeloma, Recurrence, Neoplasms

What participants receive

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

Study groups in NCT04895410
Study groupRoleWhat they receive
Dose Escalation: LemzoparlimabExperimentalParticipants will receive lemzoparlimab in 28 day cycles.
Receives: Biological: Lemzoparlimab
Dose Escalation: Lemzoparlimab + Pomalidomide + DexamethasoneExperimentalParticipants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles.
Receives: Biological: Lemzoparlimab; Drug: Dexamethasone; Drug: Pomalidomide
Dose Escalation: Lemzoparlimab + Carfilzomib + DexamethasoneExperimentalParticipants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles.
Receives: Biological: Lemzoparlimab; Drug: Dexamethasone; Drug: Carfilzomib
Dose Escalation: Lemzoparlimab + Daratumumab + DexamethasoneExperimentalParticipants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles.
Receives: Biological: Lemzoparlimab; Drug: Dexamethasone; Biological: Daratumumab
Dose Expansion: LemzoparlimabExperimentalParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles.
Receives: Biological: Lemzoparlimab
Dose Expansion: Lemzoparlimab + DexamethasoneExperimentalParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.
Receives: Biological: Lemzoparlimab; Drug: Dexamethasone
Dose Expansion: Lemzoparlimab + Pomalidomide + DexamethasoneExperimentalParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.
Receives: Biological: Lemzoparlimab; Drug: Dexamethasone; Drug: Pomalidomide
Dose Expansion: Lemzoparlimab + Carfilzomib + DexamethasoneExperimentalParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.
Receives: Biological: Lemzoparlimab; Drug: Dexamethasone; Drug: Carfilzomib
Dose Expansion: Lemzoparlimab + Daratamumab + DexamethasoneExperimentalParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.
Receives: Biological: Lemzoparlimab; Drug: Dexamethasone; Biological: Daratumumab

What is being measured

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

  1. Dose Limiting Toxicities (DLTs) of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-myeloma Regimens in Participants With Relapsed/Refractory (R/R) Multiple Myeloma (MM)

    DLT events as described in the protocol will be assessed.

    Measured: Up to 28 days after study drug administration

Secondary outcomes (4)

  1. Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better

    Best overall response is defined as achieving documented PR or better at two consecutive disease assessments during the study, according to International Myeloma Working Group (IMWG) 2016 criteria.

    Measured: Up to approximately 2 years

  2. Progression Free Survival (PFS)

    PFS is defined as the time from the first dose of study drug to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  3. Duration of Response (DOR)

    DOR is defined as the time from first documented response (PR or better) to the first documented PD or death due to MM, whichever occurs first.

    Measured: Up to approximately 2 years

  4. Time to Progression (TTP)

    TTP is defined as the time from the first dose of study drug to the first documented PD or death due to MM, whichever occurs first.

    Measured: Up to approximately 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 posted20 May 2021
  2. Study start17 Jan 2022
  3. Primary completion24 Jun 2022
  4. Study completion24 Jun 2022

Why it stopped: Strategic considerations

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895410
Sponsor's protocol ID
M20-917
Other IDs
2021-001067-24
Status last verified
Aug 2022
First submitted
19 May 2021
Last updated
6 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lemzoparlimab, Dexamethasone and Carfilzomib in people with Multiple Myeloma, run by AbbVie at 32 sites in 7 countries.

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 13 inclusion and 6 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 6 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 32 sites in United States, Israel, Spain, France, Australia and 2 more countries. 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 stopped early (reason given: Strategic considerations). Results are not available in the source record.

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?

Dose Limiting Toxicities (DLTs) of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-myeloma Regimens in Participants With Relapsed/Refractory (R/R) Multiple Myeloma (MM) (time frame: Up to 28 days after study drug administration). 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 NCT04895410.

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 6 Mar 2023.

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