Multiple MyelomaMAGNETISMM17NCT05462639
Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma
A study testing Elranatamab (PF-06863135) in people with Multiple Myeloma, run by Pfizer at 36 sites in 2 countries.
Trial summary
Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity. This expanded access protocol will provide access to elranatamab until it becomes commercially accessible to patients who are refractory to at… 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?
- Elranatamab (PF-06863135)
- How many people
- Not given
- Where
- 36 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Prior diagnosis of MM as defined according to IMWG criteria .
- Patients who are ineligible for participation in any ongoing clinical trial of elranatamab, including lack of access due to geographical limitations, and who have exhausted all other treatment options or experience lack of access to commercially available therapies due to geographical, financial or socioeconomic limitations.
- Measurable disease at screening based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL (≥5 g/L)
- Urinary M-protein excretion ≥200 mg/24 hours
- Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
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- Refractory to at least one IMiD, one PI, and one anti-CD38 antibody.
- Relapsed/refractory to last anti-MM regimen.
- ECOG performance status 0-1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Not pregnant, willing to use contraception
Who cannot join
- Smoldering MM; plasma cell leukemia; POEMS syndrome; Waldenström's macroglobulinemia; amyloidosis; stem cell transplant within 12 weeks prior to enrollment or active GVHD
- Previous treatment with BCMA directed therapy;
- Active HBV, HCV, SARS- CoV-2, HIV or any active, uncontrolled bacterial, fungal, or viral infection.
- Active infections must be resolved at least 14 days prior to enrollment.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ or Stage 0/1 with minimal risk of recurrence per treating physician.
- Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States33 sites
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
OhioHealth Arthur G.H. Bing, MD Cancer Center
Columbus, Ohio, 43214
OhioHealth Research Institute
Columbus, Ohio, 43214
MSK Commack
Commack, New York, 11725
Baylor Scott & White Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
Dallas, Texas, 75246
Baylor University Medical Center
Dallas, Texas, 75246
Texas Oncology
Dallas, Texas, 75246
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
MSK Westchester
Harrison, New York, 10604
Franciscan Health
Indianapolis, Indiana, 46237
University of Mississippi Medical Center
Jackson, Mississippi, 39213
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Memorial Sloan Kettering Cancer Center
Long Island City, New York, 11101
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
Los Angeles, California, 90095
Baptist Hospital of Miami
Miami, Florida, 33176
Miami Cancer Institute
Miami, Florida, 33176
MSK Monmouth
Middletown, New Jersey, 07748
MSK Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical College
New York, New York, 10065
UC Irvine Health
Orange, California, 92868
UC Irvine Medical Center
Orange, California, 92868
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, 33021
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, 33026
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, 33028
Memorial Hospital West Laboratory Services
Pembroke Pines, Florida, 33028
MSK Nassau
Uniondale, New York, 11553
Canada3 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: ELRANATAMAB (PF-06863135) MONOTHERAPY EXPANDED ACCESS PROTOCOL FOR TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY AND HAVE NO ACCESS TO OTHER COMPARABLE/ALTERNATIVE THERAPY
Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity.
This expanded access protocol will provide access to elranatamab until it becomes commercially accessible to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.
Read the detailed description
Study C1071017 is a single-arm, open-label study in patient with relapsed /refractory multiple myeloma.
Each patient will receive study intervention until disease progression, unacceptable toxicity, withdrawal of consent, study termination or until elranatamab becomes commercially accessible.
- Conditions
- Multiple Myeloma
- Being tested
- Elranatamab (PF-06863135)
- Keywords
- Multiple Myeloma, Erlanatamab, Expanded Access, MM17, MagnetisMM-17, BCMA, BCMA antibody, Advanced multiple myeloma, Relapse/Refractory, RRMM, MagnetisMM, MagnetisMM US, Bispecific Antibody
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elranatamab (PF-06863135)Drug
BCMA-CD3 bispecific antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462639
- Sponsor's protocol ID
- C1071017
- Acronym
- MAGNETISMM17
- Status last verified
- Aug 2024
- First submitted
- 20 Jun 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELRANATAMAB (PF-06863135) MONOTHERAPY EXPANDED ACCESS PROTOCOL FOR TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY AND HAVE NO ACCESS TO OTHER COMPARABLE/ALTERNATIVE THERAPY
- ClinicalTrials.gov ID
- NCT05462639
- Acronym / sponsor ID
- MAGNETISMM17 / C1071017
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Erlanatamab, Expanded Access, MM17, MagnetisMM-17, BCMA, BCMA antibody, Advanced multiple myeloma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity.
This expanded access protocol will provide access to elranatamab until it becomes commercially accessible to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.
Detailed description
Study C1071017 is a single-arm, open-label study in patient with relapsed /refractory multiple myeloma.
Each patient will receive study intervention until disease progression, unacceptable toxicity, withdrawal of consent, study termination or until elranatamab becomes commercially accessible.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Prior diagnosis of MM as defined according to IMWG criteria .
- Patients who are ineligible for participation in any ongoing clinical trial of elranatamab, including lack of access due to geographical limitations, and who have exhausted all other treatment options or experience lack of access to commercially available therapies due to geographical, financial or socioeconomic limitations.
- Measurable disease at screening based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL (≥5 g/L)
- Urinary M-protein excretion ≥200 mg/24 hours
Key exclusion criteria (6 listed)
- Smoldering MM; plasma cell leukemia; POEMS syndrome; Waldenström's macroglobulinemia; amyloidosis; stem cell transplant within 12 weeks prior to enrollment or active GVHD
- Previous treatment with BCMA directed therapy;
- Active HBV, HCV, SARS- CoV-2, HIV or any active, uncontrolled bacterial, fungal, or viral infection.
- Active infections must be resolved at least 14 days prior to enrollment.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ or Stage 0/1 with minimal risk of recurrence per treating physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elranatamab (PF-06863135)BCMA-CD3 bispecific antibody | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elranatamab (PF-06863135) in people with Multiple Myeloma, run by Pfizer at 36 sites in 2 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 11 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada. 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.
Are results available for this study?
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.
Where can I read the original study information?
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 9 Aug 2024.