Relapsed and/or Refractory Multiple MyelomaPhase 1NCT04017130

A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing MT-0169 in people with Relapsed and/or Refractory Multiple Myeloma, run by Molecular Templates, Inc. 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 will be a Phase 1 Open-Label, dose escalation of MT-0169 (an Engineered toxin body (ETB) in patients with relapsed or refractory multiple myeloma. MT-0169 is an investigational drug that recognizes and binds to the CD38 receptor, which may be found on the surface of multiple myeloma cancer cells. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed and/or Refractory Multiple Myeloma
What is being tested?: MT-0169
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 7 sitesUnited States
Study dates: 5 Feb 2020to 13 Dec 2023
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

Confirmed diagnosis of MM per revised IMWG diagnostic criteria
Patients with RRMM who have failed treatment with, are intolerant to, or are not candidates for available therapies that are known to confer clinical benefit
Must meet all of the following criteria for prior therapy:
Must be refractory to ≥1 proteasome inhibitor (PI), ≥1 immunomodulatory drug (IMiD), and ≥1 steroid
Must either have received ≥3 prior lines of therapy or ≥2 prior lines of therapy if 1 line included a combination of PI and IMiD (prior treatment with anti-CD38 therapy is permitted).
With measurable disease, defined as ≥1 of the following:

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Serum M-protein ≥500 mg/dL (≥5 g/L) on serum protein electrophoresis (SPEP).
Urine M-protein ≥200 mg/24 h on urine protein electrophoresis (UPEP).
Serum FLC assay result with an involved FLC level ≥10 mg/dL (≥100 mg/L) if serum FLC ratio is abnormal.
Patients with serum M-protein, urine M-protein, or involved immunoglobulin FLC not meeting the measurable disease criteria above will be eligible if they have ≥1 of the following:
Bone marrow (BM) aspirate/biopsy with plasma cell percentage ≥30%
PET imaging with ≥1 plasmacytoma lesion with a single diameter of ≥2cm.
With Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
With the following cardiovascular parameters:
Left ventricular ejection fraction (LVEF) > 50% by echocardiogram or cardiac MRI.
Cardiac troponin (high sensitivity or conventional) and NT-proBNP or BNP values within the institutional normal range
QT interval corrected by the Fridericia method (QTcF) on screening electrocardiogram (ECG)[ QTcF of ≤450 millisecond (ms) in males or ≤470 ms in females]
Must meet the following clinical laboratory criteria at entry:
Total bilirubin ≤1.5*the upper limit of the normal range (ULN), except for Gilbert's syndrome (direct bilirubin must be <2.0*ULN)
Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5*ULN.
Estimated glomerular filtration rate (eGFR) ≥30 (mL/min/1.73 square meter [m2]), using the modification of diet in renal disease (MDRD) equation
Absolute neutrophil count (ANC) ≥1000 per cubic millimeter (/mm3) (≥1.0*109 per liter [/L]); ≥750/mm3 (≥0.75*109/L) may be acceptable for participants with >50% of plasma cells in BM
Platelet count ≥75,000/ mm3 (≥75*109/L); ≥50,000/ mm3 (≥50*109/L) may be acceptable for participants with ≤ 50% of plasma cells in BM
Hemoglobin ≥7.5 g/dL without transfusion within 7 days before the lab test.
Serum albumin ≥2.5 g/dL.
Female patients who:
are postmenopausal for at least 1 year prior to screening OR
are surgically sterile OR
If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective barrier method at the same time from study entry through 30 days after the last dose of study drug OR
agree to practice true abstinence if in line with the preferred, usual lifestyle [periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable. Female and male condoms should not be used together]
Male patients, even if surgically sterilized (postvasectomy) who:
Agree to practice effective barrier contraception during the entire study and through 90 days after last dose of study drug OR
Agree to practice true abstinence if in line with the preferred, usual lifestyle [periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable. Female and male condoms should not be used together]
Confirmed diagnosis of MM per IMWG diagnosis criteria:
RRMM, having failed treatment with, is intolerant to, or is determined not to be a candidate for available therapies considered SOC or are known to confer clinical benefit.
Must meet the following criteria for prior therapy:
Refractory or intolerant to at least 1 proteasome inhibitor (PI) and at least 1 immunomodulatory drug (IMiD), and at least 1 steroid.
Receipt of ≥3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 therapy such as daratumumab and isatuximab.
Measurable disease, defined as ≥1 of the following
Serum M-protein ≥50 mg/dL (≥5 g/L) on SPEP.
Urine M-protein ≥200 mg/24 hours on UPEP.
Serum FLC assay result with and involved FLC level ≥10 mg/dL (≥100mg/L), provided the serum FLC ratio is abnormal.
Serum M-protein, urine M-protein or involved immunoglobulin FLC not meeting measurable disease criteria if they have extramedullary disease with either:
Imaging showing at least 1 extramedullary lesion (except CNS listed below that has a single diameter of ≥2 cm, or
Plasma cell leukemia.

Who cannot join

With polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, amyloidosis, Waldenström macroglobulinemia, or Immunoglobulin M (IgM) myeloma.
With sensory or motor neuropathy of NCI CTCAE V5 Grade ≥3.
Have received final dose of any of the following treatments/procedures within the following interval before the first dose of MT-0169:
Myeloma-specific therapy, including PIs and IMiDs: 14 days
Anti-CD38 (a) therapy: Isatuximab 90 days; daratumumab 60 days
Corticosteroid therapy for myeloma: 7 days

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Radiation therapy for localized bone lesions: 14 days
Major surgery:30 days
Autologous stem cell transplant: 90 days
Investigational therapy: 30 days
Have received an allogeneic stem cell transplant or organ transplantation.
Have not recovered to Grade ≤1 or baseline, from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) excluding alopecia and Grade 2 neuropathy.
With clinical signs of central nervous system (CNS) involvement of MM.
With a history of myelodysplastic syndrome or another malignancy other than MM except for the following: any malignancy in complete remission for 3 years, adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, or asymptomatic prostate cancer without known metastatic disease and not requiring therapy or requiring only hormonal therapy and with normal prostate-specific antigen level for ≥1 year before the start of study therapy.
With known or suspected light chain amyloidosis of any organ (amyloid on the BM biopsy without other evidence of amyloidosis is acceptable).
With any of the following cardiovascular conditions:
Congestive heart failure (NYHA) class ≥II or cardiomyopathy, active ischemia, or any other uncontrolled cardiac condition or myocardial infarction or clinically significant arrhythmia requiring therapy including anticoagulants within the past 6 months or at screening (stable therapy for > 6 months is acceptable).
Resting tachycardia (heart rate of > 100 bpm) at screening
Clinically significant uncontrolled hypertension at screening
Cardiac MRI at screening demonstrates evidence of amyloid cardiomyopathy or myocarditis
With a history of documented significant pleural or pericardial effusions of at least CTCAE Grade 3 within 3 months before the start of treatment. This will also exclude patients with:
Pericarditis (any Grade)
Non-malignant pleural effusion (Grade ≥2)
Patients with a history of noncardiogenic pulmonary edema associated with diffuse peripheral edema and history of intravascular hypovolemia associated with systemic antineoplastic therapy.
With chronic or active infection requiring systemic therapy, history of symptomatic viral infection that has not been fully cured. The following exceptions apply for those with positive serologies of HIV, HBV, or HCV:
With HIV and an undetectable viral load and CD4+ T-cell (CD4+) counts ≥350 cells/mL may be allowed but patient must be taking appropriate opportunistic infection prophylaxis if clinically relevant
With positive HBV serology may be allowed if undetectable viral load, receiving antiviral prophylaxis for potential HBV reactivation per institutional guidelines
With positive HCV serology may be allowed if quantitative PCR for plasma HCV RNA is below the lower limit of detection. Concurrent antiviral HCV treatment per institutional guidelines is allowed.
Have received a live attenuated vaccine within 28 days of first dose of MT-0169.
With a history of CTCAE Grade 3 ≥ systemic inflammatory response syndrome (SIRS)/ cytokine release syndrome (CRS) reactions following infusion with any monoclonal antibodies (mAbs) or Chimeric Antigen Receptor (CAR) T therapy
With a chronic condition requiring systemic corticosteroids at >10 mg/day of prednisone or equivalent.
Are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or patients of reproductive potential who are not employing an effective birth control
With a concurrent medical or psychiatric illness that would preclude study conduct and assessment including, but not limited to, uncontrolled medical conditions, active infection, risk of bleeding, diabetes mellitus, pulmonary disease, alcoholic liver disease, or primary biliary cirrhosis.
With known allergy or intolerance to any of the drugs used in the study or excipients in MT-0169
With a history of hypersensitivity or serious toxic reaction to kanamycin or another aminoglycoside.
Failed to recover to Grade ≤1 or baseline from adverse reactions to prior treatment or procedures (chemotherapy, immunotherapy, radiation therapy) excluding alopecia and stable Grade 2 neuropathy.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Northside Hospital
Atlanta, Georgia, 30342
The Ohio State University
Columbus, Ohio, 43201
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
University of Southern California
Los Angeles, California, 90033
Miami University
Miami, Florida, 33136
Vanderbilt University Medical Center- Ingram Cancer Center
Nashville, Tennessee, 37203
Mayo Clinic - Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MT-0169 in Patients With Relapsed or Refractory Multiple Myeloma

Read the detailed description

The drug being tested in this study is called MT-0169. The study will evaluate the safety, tolerability, preliminary efficacy, PK, pharmacodynamics, and immunogenicity of MT-0169 monotherapy in participants with RRMM.

The study will enroll up to 54 total participants.

The purpose of this study is to evaluate the safety and tolerability of MT-0169 in subjects with relapsed or refractory multiple myeloma (RRMM) and to estimate the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D).

MT-0169 will be given as an intravenous (IV) infusion over 60 minutes on the same day every week (i.e., days 1, 8, 15 and 22) or every 2 weeks (i.e., days 1 and 15) of each cycle. A cycle is defined as 28 days.

A subject may participate for the following three (3) periods:

Screening Period - up to 28 days before first dose of MT-0169 Treatment Period - active period where a subject will receive doses of MT-0169 over a 28-day treatment period Follow-up Period - up to 12 months after the last patient in the study to receive the last dose of MT-0169.

Participants can receive MT-0169 until the cancer worsens, side effects prevent further study treatment, or until the participant leaves the study for other reasons decided by the participant, the study doctor, or the sponsor of the study. After treatment has finished, participants will have a check-up of their disease status every 12 weeks.

This multi-center trial will be conducted in the United States. The overall duration of the study will vary for each participant because they will receive study treatment until unacceptable toxicity, withdrawal of consent, death, termination of the study by the sponsor, or fulfillment of another discontinuation criterion. Participants will be followed up for 30 days after the last dose of study drug for a follow-up assessment for any side effects. Participants will then be followed every 12 weeks to check for the status of their disease up to 12 months after the last subject on the trial has the last dose of study drug, or the sponsor discontinues the study, whichever occurs first.

Conditions: Relapsed and/or Refractory Multiple Myeloma
Being tested: MT-0169
Keywords: Drug therapy

What participants receive

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

MT-0169Drug
MT-0169 intravenous infusion.

Study groups in NCT04017130
Study group	Role	What they receive
Part 1: Dose Escalation	Experimental	Weekly Dosing Intravenous (IV) infusion of MT-0169 every 7 days: Days 1, 8, 15, and 22 in a 28-day treatment cycle. Every 2 Weeks IV infusion of MT-0169 every 14 days: Days 1 and 15 in a 28-day treatment cycle with escalating doses starting at the MTD/RP2D determined by the weekly dose escalation cohort. Patients will continue to receive treatment until progressive disease, unacceptable toxicity or withdraw from the study for other reasons. Decision to escalate/deescalate/stay on the same dose/discontinue MT-0169 will be based on number of DLTs per number of patients enrolled at each dose level as predetermined by the mTPI-2 statistical model. Subsequent doses will be determined by the frequency and severity of adverse events in previous cohorts. The investigator and sponsor review of available safety, PK, pharmacodynamics, and efficacy data in the previous cohorts will also be factored in the decision. Receives: Drug: MT-0169

What is being measured

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

Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Measured: Up to 12 months
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 12 months
Number of participants with Dose-limiting Toxicities (DLTs)
Measured: Up to 12 months
Number of participants with Grade greater than or equal to (>=) 3 TEAEs according to NCI CTCAE 5.0
Measured: Up to 12 months
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to 12 months
Number of participants who discontinued MT-0169 due to TEAEs
Measured: Up to 12 months
Number of participants with treatment-related dose modifications
Dose modifications include dose delays, dose interruptions, and dose reductions
Measured: Up to 12 months

Secondary outcomes (12)

Cmax: maximum observed concentration for MT-0169
Measured: Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days)
Tmax: time to reach maximum observed concentration for MT-0169
Measured: Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days)
AUClast: Area Under the Concentration-time Curve From Time 0 to the time of the last quantifiable concentration for MT-0169
Measured: Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days)
Overall response rate (ORR)
As defined by IMWG Uniform Response Criteria for RRMM patients.
Measured: Up to 12 months
Clinical Benefit Rate (CBR) for RRMM patients
Percentage of participants who achieved PR or better during study as defined by IMWG Uniform Response Criteria and ORR in patients with RRNHL as defined by the Lugano classification for lymphoma.
Measured: Up to 12 months
Progression-free Survival (PFS) for RRMM patients
Determined by IMWG criteria
Measured: From the date of first dose until the date of progressive disease (PD)
Proportion of RRMM participants who achieved MR (minimal response)
MR is defined as the percentage of participants who achieved 25% tumor reduction.
Measured: Up to 12 months
Duration of Response (DOR)
Time from the date of the first documentation of response to the date of the first documented PD.
Measured: Date of the dose administration until death due to any cause (up to 12 months)
Number of participants with Anti-drug Antibodies following administration of MT-0169
Measured: Up to 12 months
Overall survival (OS)
Measured: From date of the dose administration until death due to any cause (up to 12 months)
Time to Response (TTR)
Measured: From the date of the first dose of the study treatment to the date of the first documentation of response (up to 12 months)
Percentage of participants with RRMM who achieved Complete Response (CR) or Very Good Partial Response (VGPR)
Measured: Up to 12 months

Timeline

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

5 Feb 202013 Dec 2023

First posted12 Jul 2019
Study start5 Feb 2020
Primary completion13 Dec 2023
Study completion13 Dec 2023

Why it stopped: Sparse/no patient enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapsed and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04017130
Sponsor's protocol ID: MT-0169-001
Other IDs: U1111-1224-6002, 2019-000931-24, 2019
Status last verified: Jan 2024
First submitted: 10 Jul 2019
Last updated: 17 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
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All Relapsed and/or Refractory Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MT-0169 in Patients With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT04017130
Acronym / sponsor ID: MT-0169-001
Conditions: Relapsed and/or Refractory Multiple Myeloma
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sparse/no patient enrollment
Enrolment: 14 participants (actual)
Lead sponsor: Molecular Templates, Inc.Industry (pharma, biotech, devices)
Study start: 5 Feb 2020 (actual)
Primary completion: 13 Dec 2023 (actual)
Study completion: 13 Dec 2023 (actual)
First posted: 12 Jul 2019 (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.

Detailed description

The study will enroll up to 54 total participants.

A subject may participate for the following three (3) periods:

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Part 1: Dose Escalation	Experimental	Drug: MT-0169Weekly Dosing Intravenous (IV) infusion of MT-0169 every 7 days: Days 1, 8, 15, and 22 in a 28-day treatment cycle. Every 2 Weeks IV infusion of MT-0169 every 14 days: Days 1 and 15 in a 28-day treatment cycle with escalating doses starting at the MTD/RP2D determined by the weekly dose escalation cohort. Patients will continue to receive treatment until progressive disease, unacceptable toxicity or withdraw from the study for other reasons. Decision to escalate/deescalate/stay on the same dose/discontinue MT-0169 will be based on number of DLTs per number of patients enrolled at each dose level as predetermined by the mTPI-2 statistical model. Subsequent doses will be determined by the frequency and severity of adverse events in previous cohorts. The investigator and sponsor review of available safety, PK, pharmacodynamics, and efficacy data in the previous cohorts will also be factored in the decision.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (45 listed)

Confirmed diagnosis of MM per revised IMWG diagnostic criteria
Patients with RRMM who have failed treatment with, are intolerant to, or are not candidates for available therapies that are known to confer clinical benefit
Must meet all of the following criteria for prior therapy:
With measurable disease, defined as ≥1 of the following:
Patients with serum M-protein, urine M-protein, or involved immunoglobulin FLC not meeting the measurable disease criteria above will be eligible if they have ≥1 of the following:

Key exclusion criteria (36 listed)

With polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, amyloidosis, Waldenström macroglobulinemia, or Immunoglobulin M (IgM) myeloma.
With sensory or motor neuropathy of NCI CTCAE V5 Grade ≥3.
Have received final dose of any of the following treatments/procedures within the following interval before the first dose of MT-0169:
Have received an allogeneic stem cell transplant or organ transplantation.
Have not recovered to Grade ≤1 or baseline, from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) excluding alopecia and Grade 2 neuropathy.

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
MT-0169MT-0169 intravenous infusion.	Drug	Part 1: Dose Escalation

Primary outcome

Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Time frame: Up to 12 months
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 12 months
Number of participants with Dose-limiting Toxicities (DLTs)
Time frame: Up to 12 months
Number of participants with Grade greater than or equal to (>=) 3 TEAEs according to NCI CTCAE 5.0
Time frame: Up to 12 months
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 12 months
Number of participants who discontinued MT-0169 due to TEAEs
Time frame: Up to 12 months
Number of participants with treatment-related dose modifications
Time frame: Up to 12 months
Dose modifications include dose delays, dose interruptions, and dose reductions

12 secondary outcomes

Cmax: maximum observed concentration for MT-0169
Time frame: Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days)
Tmax: time to reach maximum observed concentration for MT-0169
Time frame: Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days)
AUClast: Area Under the Concentration-time Curve From Time 0 to the time of the last quantifiable concentration for MT-0169
Time frame: Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days)
Overall response rate (ORR)
Time frame: Up to 12 months
Clinical Benefit Rate (CBR) for RRMM patients
Time frame: Up to 12 months
Progression-free Survival (PFS) for RRMM patients
Time frame: From the date of first dose until the date of progressive disease (PD)
Proportion of RRMM participants who achieved MR (minimal response)
Time frame: Up to 12 months
Duration of Response (DOR)
Time frame: Date of the dose administration until death due to any cause (up to 12 months)
Number of participants with Anti-drug Antibodies following administration of MT-0169
Time frame: Up to 12 months
Overall survival (OS)
Time frame: From date of the dose administration until death due to any cause (up to 12 months)
Time to Response (TTR)
Time frame: From the date of the first dose of the study treatment to the date of the first documentation of response (up to 12 months)
Percentage of participants with RRMM who achieved Complete Response (CR) or Very Good Partial Response (VGPR)
Time frame: Up to 12 months

Results and safety

The study was stopped early (reason given: Sparse/no patient enrollment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
Individual participant dataSharing planned: No

Related trials for Relapsed and/or Refractory Multiple Myeloma

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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.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MT-0169 in people with Relapsed and/or Refractory Multiple Myeloma, run by Molecular Templates, Inc. 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 45 inclusion and 36 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 17 Jan 2024. 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 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: Sparse/no patient enrollment). 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?

Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) (time frame: Up to 12 months). The study lists 7 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 NCT04017130.

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 17 Jan 2024.