AzTrials
AzTrials

Relapsed/Refractory Multiple MyelomaPhase 1ProxiMMity-1NCT04998747

A Study of Subcutaneous (SC) AMG 701 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

A Phase 1 study testing AMG 701 in people with Relapsed/Refractory Multiple Myeloma, run by Amgen.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

A study to evaluate the safety and tolerability of subcutaneous (SC) AMG 701 in participants with relapsed or refractory multiple myeloma (RRMM) to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
AMG 701
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
29 Aug 2023to 28 Aug 2025
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

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age 18 years or older at the time of signing the informed consent.
  • Relapsed or relapsed and refractory multiple myeloma according to International Myeloma Working Group (IMWG) criteria.
  • Participants must have received ≥ 3 prior therapies that must include all approved and available therapies deemed eligible by the investigator, including at a minimum, a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and a CD38-directed antibody. Note: Participants may have received prior treatment targeting BCMA that is not AMG 701.
  • Participants must have measurable disease, defined by 1 or more of the following at time of screening :
  • A serum M protein ≥ 0.5 g/dL measured by serum protein electrophoresis (SPEP)
Show all 26Show fewer
  • Urinary M protein excretion ≥ 200 mg/24 hours
  • Involved serum free light chain (sFLC) measurement ≥ 10 mg/dL, provided that SFLC ratio is abnormal as per IMWG response criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Life expectancy of at least 3 months as per investigator's judgment at time of screening
  • Hematological function without transfusion support as follows:
  • Absolute neutrophil count ≥ 1.0 x 10^9/L (without growth factor support)
  • Platelet count ≥ 50 x 10^9/L (without transfusions within 7 days from screening assessment)
  • Hemoglobin ≥ 8.0 g/dL (transfusions permitted no later than 48 hours before screening)
  • Renal function as follows:
  • Calculated or measured creatinine clearance ≥ 30 mL/min using:
  • The Cockcroft-Gault equation OR
  • Via 24-hour urine collection with plasma and urine creatinine concentrations
  • Hepatic function as follows:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
  • Total bilirubin (TBIL) < 1.5 x ULN (unless considered due to Gilbert's syndrome)
  • Cardiac function as follows:
  • Left ventricular ejection fraction ≥ 50% as assessed by transthoracic echocardiogram (TTE) or multigated acquisition (MUGA) scan.
  • Serum sodium, potassium, phosphorus, calcium, and magnesium must be within normal range or if outside normal range must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 within 7 days of day 1. Participants not meeting these inclusion criteria may be treated with replacement therapy and re-screened up to 2 times at the discretion of the investigator.
  • Participants with prior COVID-19 infection or history of cardiovascular disease including coronary artery disease, significant valvular disease, cardiac arrhythmia, cardiomyopathy, or history of cardiac toxicity with prior therapy must have a cardiology consultation during screening with a clinical management plan during cytokine release syndrome (CRS) prior to cycle 1 day 1 therapy.
  • Participants with a history of COVID-19 infection must be discussed with the medical monitor prior to enrollment. Participants with a history of COVID-19 infection must have a negative quantitative polymerase chain reaction (PCR) test prior to enrollment.

Who cannot join

  • Known central nervous system involvement by multiple myeloma.
  • Recent history of primary plasma cell leukemia (within last 6 months prior to enrollment) or evidence of primary or secondary plasma cell leukemia at the time of screening.
  • Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes), or amyloidosis (participants with multiple myeloma with asymptomatic amyloid plaques found on biopsy would be eligible if all other criteria are met).
  • History or evidence of any of the following cardiovascular disorders:
  • Active congestive heart failure (New York Heart Association Class III to IV)
  • Symptomatic ischemia
Show all 50Show fewer
  • Uncontrolled arrhythmias
  • Screening ECG with corrected QT interval (QTc) of > 470 msec
  • Myocardial infarction within 12 months prior to study day 1
  • History of malignancy other than multiple myeloma within the past 3 years with the following exceptions:
  • Malignancy treated with curative intent and with no known active disease present for at least 1 year before enrollment and felt to be at low risk for recurrence by the treating physician.
  • Adequately treated cervical carcinoma in situ without evidence of disease.
  • Breast ductal carcinoma in situ with full surgical resection (ie, negative margins) and without evidence of disease
  • Prostate cancer with a Gleason score < 7 with undetectable prostate specific antigen over 12 months
  • Treated medullary or papillary thyroid cancer
  • Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
  • Similar neoplastic conditions with an expectation of > 95% 5-year disease-free survival
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Clinically uncontrolled chronic or ongoing bacterial, fungal, viral, or other infectious disease at study day 1 or within 14 days before study day 1.
  • Positive result for human immunodeficiency virus (HIV).
  • Active hepatitis B and C based on the following results:
  • Positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
  • Negative HepBsAg and positive for hepatitis B core antibody: Either a positive hepatitis B surface antibody or a negative hepatitis B virus DNA by PCR result is necessary for enrollment
  • Positive hepatitis C virus antibody: Negative hepatitis C virus RNA by PCR result is necessary for enrollment
  • Unresolved toxicities from prior anticancer therapy, defined as not having resolved to CTCAE version 5.0 grade 1 or to levels dictated in the eligibility criteria with the exception of grade 2 peripheral neuropathy, alopecia or toxicities from prior anticancer therapy that are considered irreversible (defined as having been present and stable for > 4 weeks) which may be allowed if they are not otherwise described in the exclusion criteria and there is agreement to allow by both the investigator and Amgen medical monitor.
  • Known hypersensitivity to immunoglobulins.
  • Current autoimmune disease that is not well-controlled.
  • Past history or current significant inflammatory neuropathy such as Guillain-Barré syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, or Multifocal motor neuropathy.
  • Previously received an allogeneic stem cell transplant and the occurrence of 1 or more of the following:
  • Received the transplant within 6 months prior to study day 1
  • Received immunosuppressive therapy within the last 3 months prior to study day 1
  • Any active acute graft versus host disease (GvHD) requiring systemic therapy within the last 4 weeks prior to start of study treatment
  • Any systemic therapy against GvHD within 4 weeks prior to start of investigational product treatment
  • Autologous stem cell transplantation less than 90 days prior to study day 1.
  • Last non-antibody anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks and last anticancer therapeutic antibody < 4 weeks prior to study day 1.
  • Lymphodepleting chemotherapy (eg, fludarabine, cyclophosphamide, or anti-CD52 antibody in association with chimeric antigen-receptor T-cell therapy) < 3 months prior to study day 1.
  • Radiation therapy to multiple anatomic sites within 28 days prior to study day 1.
  • Focal radiotherapy within 14 days prior to study day 1.
  • Treatment with systemic immune modulators including, but not limited to, non-topical systemic corticosteroids (unless the dose is less ≤ 10 mg/day prednisone or equivalent), cyclosporine, and tacrolimus within 2 weeks before study day 1.
  • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
  • Administration of bone preserving therapies (including bisphosphonates) within 14 days of cycle 1 day 1.
  • Major surgery defined as surgery requiring general anesthesia with endotracheal intubation within 28 days prior to study day 1, unless discussed with and eligibility approved by Amgen medical monitor.
  • Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 75 days after the last dose of AMG 701.
  • Female participants who are breastfeeding or who plan to breastfeed while on study through 75 days after the last dose of AMG 701.
  • Female participants planning to become pregnant while on study through 75 days after the last dose of AMG 701.
  • Female participants with a positive pregnancy test.
  • Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 135 days after the last dose of AMG 701.
  • Male participants unwilling to abstain from donating sperm during treatment and for an additional 135 days after the last dose of AMG 701.
  • Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

About this study

Official title: A Phase 1b Open-label Study Evaluating the Safety and Pharmacokinetics of Subcutaneous AMG 701 for the Treatment of Relapsed or Refractory Multiple Myeloma (ProxiMMity-1)

A study to evaluate the safety and tolerability of subcutaneous (SC) AMG 701 in participants with relapsed or refractory multiple myeloma (RRMM) to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)

Being tested
AMG 701
Keywords
AMG 701, Relapsed/Refractory Multiple Myeloma, B-cell maturation antigen (BCMA)
Medical subject headings
Multiple Myeloma

What participants receive

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

  • AMG 701Drug

    AMG 701 will be administered as SC or intravenous injection.

  • AMG 701Drug

    AMG 701 will be administered as SC injection.

Study groups in NCT04998747
Study groupRoleWhat they receive
AMG 701: dose explorationExperimentalCohorts of 3 to 6 participants each will be administered AMG 701 at different doses to determine the RP2D based on occurence of dose-limiting toxicities (DLTs) and on emerging safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy data.
Receives: Drug: AMG 701
AMG 701: dose expansionExperimentalParticipants will be administered AMG 701 at the RP2D determined from dose exploration stage to further assess the safety, PK, PD, and efficacy of the selected dose.
Receives: Drug: AMG 701

What is being measured

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

  1. Number of participants who experience dose-limiting toxicities (DLTs)

    Measured: 28 days

  2. Number of participants who experience one or more treatment-emergent adverse events (TEAEs)

    Measured: up to approximately 9 months

  3. Number of participants who experience one or more treatment-related TEAEs

    Measured: up to approximately 9 months

  4. Number of participants with abnormal changes in vital signs

    Measured: up to approximately 9 months

  5. Number of participants with abnormal changes in electrocardiograms (ECGs) findings

    Measured: up to approximately 9 months

  6. Number of participants with abnormal changes in clinical laboratory tests

    Measured: up to approximately 9 months

Secondary outcomes (11)

  1. Maximum serum concentration (Cmax) of AMG 701

    Measured: up to approximately 8 months

  2. Time to maximum concentration (Tmax) of AMG 701

    Measured: up to approximately 8 months

  3. Area under the concentration-time curve (AUC) of AMG 701

    Measured: up to approximately 8 months

  4. Minimum concentration over the dosing interval (Ctrough) of AMG 701

    Measured: up to approximately 8 months

  5. Incidence of anti-AMG 701 antibody formation

    Measured: up to approximately 9 months

  6. Overall response (OR)

    Measured: up to approximately 8 months

  7. Best overall response (BOR)

    Measured: up to approximately 8 months

  8. Time to response

    Measured: up to approximately 8 months

  9. Duration of response (DOR)

    Measured: up to approximately 8 months

  10. Progression-free survival (PFS)

    Measured: up to approximately 3 years

  11. Overall survival (OS)

    Measured: up to approximately 3 years

Timeline

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

  1. First posted10 Aug 2021
  2. Study start29 Aug 2023 (estimated)
  3. Primary completion2 Aug 2025 (estimated)
  4. Study completion28 Aug 2025 (estimated)

Why it stopped: Amgen Decision to stop development of AMG 701 SC, not for safety reasons but for business reasons.

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
Basic science
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04998747
Sponsor's protocol ID
20200446
Acronym
ProxiMMity-1
Status last verified
Sep 2022
First submitted
2 Aug 2021
Last updated
27 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 701 in people with Relapsed/Refractory Multiple Myeloma, run by Amgen.

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 26 inclusion and 50 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 Sep 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 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 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?

Number of participants who experience dose-limiting toxicities (DLTs) (time frame: 28 days). The study lists 6 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 NCT04998747.

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 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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