MT-0169 for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Miami University, Miami, FL
Multiple Myeloma+5 More
MT-0169 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

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

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Eligible Conditions

  • Multiple Myeloma
  • Relapsed and/or Refractory Non Hodgkin Lymphoma
  • Relapsed Or Refractory Multiple Myeloma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether MT-0169 will improve 16 primary outcomes and 37 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days).

Day 28
Part 1 and Part 2, AUClast: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-169
Part 1 and Part 2, AUClast: Area Under the Concentration-time Curve From Time 0 to the time of the last quantifiable concentration for MT-0169
Part 1 and Part 2, Cmax: Maximum Observed Concentration for TAK-169
Part 1 and Part 2, Cmax: maximum observed concentration for MT-0169
Part 1 and Part 2, Tmax: Time to Reach the Maximum Observed Concentration (Cmax) for TAK-169
Part 1 and Part 2, Tmax: time to reach maximum observed concentration for MT-0169
Month 12
Part 1 and Part 2: Duration of Response (DOR)
Part 1 and Part 2: Progression-free Survival (PFS)
Month 12
Part 1 and Part 2: overall survival (OS)
Part 2: Overall Survival (OS)
Part 2: overall survival
From the date of first dose until the date of progressive disease (PD)
Part 1 and Part 2: Progression-free Survival (PFS) for RRMM patients
Part 1 and Part 2: Progression-free Survival (PFS) for RRNHL patients
Month 12
Part 1 and Part 2: Time to Response (TTR)
Part 2: Time to Response (TTR)
Up to 12 months
Part 1 and Part 2: Clinical Benefit Rate (CBR) for RRMM patients
Part 1 and Part 2: Disease Control Rate (DCR) for RRNHL patients
Part 1 and Part 2: Number of Participants With Anti-drug Antibodies Following Administration of TAK-169
Part 1 and Part 2: Percentage of Participants who Achieved MR
Part 1 and Part 2: Proportion of RRMM participants who achieved MR (minimal response)
Part 1 and Part 2: number of participants with Anti-drug Antibodies following administration of MT-0169
Part 1 and Part 2: percentage of RRMM participants who achieved MR (minimal response)
Part 1 and Part 2: percentage of participants with RRMM who achieved Complete Response (CR) or Very Good Partial Response (VGPR)
Part 1: Clinical Benefit Rate (CBR)
Part 1: Number of Participants Who Discontinued TAK-169 Due to TEAEs
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) at Each Dose Level
Part 1: Number of Participants With Grade Greater Than or Equal to (>=) 3 TEAEs
Part 1: Number of Participants With Overall and per Dose Level Treatment-emergent Adverse Events (TEAEs)
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Part 1: Number of Participants With Treatment Related Dose Modifications Including Dose Delays, Dose interruption and Dose Reductions
Part 1: ORR
Part 1: maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Part 1: number of participants who discontinued MT-0169 due to TEAEs
Part 1: number of participants with Dose-limiting Toxicities (DLTs)
Part 1: number of participants with Treatment-emergent Adverse Events (TEAEs)
Part 1: number of participants with treatment-related dose modifications
Part 1: overall response rate (ORR)
Part 1:number of participants with Grade greater than or equal to (>=) 3 TEAEs according to NCI CTCAE 5.0
Part 1:number of participants with Serious Adverse Events (SAEs)
Part 2: Number of Participants With DLTs and Other TEAEs Including Dose Modifications, Treatment Discontinuation, and Vital signs
Part 2: ORR for RRNHL patients
Part 2: Overall Response Rate (ORR)
Part 2: Percentage of Participants Who Achieved Complete Response (CR) or Very Good Partial Response (VGPR)
Part 2: measurement of RRNHL disease control rate (DCR)
Part 2: measurement of RRNHL tumor CD38 expression level
Part 2: number of participants with DLTs
Part 2: number of participants with NHL requiring dose modifications.
Part 2: number of participants with NHL with Grade Greater Than or Equal to (>=) 3 TEAEs
Part 2: number of participants with NHL with SAEs
Part 2: number of participants with NHL with TEAEs
Part 2: number of participants with TEAEs
Part 2: overall response rate (ORR) for RRMM patients
Part 2: percentage of participants who achieved Complete Response (CR) or Very Good Partial Response (VGPR)

Trial Safety

Trial Design

12 Treatment Groups

Part 2: Dose Expansion in Patients with RRMM who are also Daratumumab RR: Every ...
1 of 12
Part 1: Dose Escalation
1 of 12
Part 1: Dose Escalation in Patients with Refractory or Relapsing MM
1 of 12
Part 2 Biweekly: Dose Expansion in Patients with Refractory or Relapsing NHL
1 of 12
Part 2: Dose Expansion in patients with RRNHL: Weekly Dosing
1 of 12
Part 2: Dose Expansion in Patients with Refractory or Relapsing MM, Anti-CD38 Th...
1 of 12
Part 2: Dose Expansion in patients with RRNHL: Every 2 Weeks
1 of 12
Part 2: Dose Expansion in Patients with RRMM who are Anti-CD38 Therapy naïve: We...
1 of 12
Part 2: Dose Expansion in Patients with RRMM who are also Daratumumab RR: Weekly...
1 of 12
Part 2 Weekly: Dose Expansion in Patients with Refractory or Relapsing MM, Darat...
1 of 12
Part 2 Weekly: Dose Expansion in Patients with Refractory or Relapsing NHL
1 of 12
Part 2 Biweekly: Dose Expansion in Patients with Refractory or Relapsing MM, Dar...
1 of 12
Experimental Treatment

This trial requires 144 total participants across 12 different treatment groups

This trial involves 12 different treatments. MT-0169 is the primary treatment being studied. Participants will be divided into 12 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Part 2: Dose Expansion in Patients with RRMM who are also Daratumumab RR: Every 2 Weeks
Drug
Each cohort will receive intravenous infusion of MT-0169 every 14 days on Days 1 and 15 in a 28- days treatment cycle. The dose administered will be the MTD/RP2D in the Biweekly Dose Escalation of Part 1.
Part 1: Dose Escalation
Drug
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.
Part 1: Dose Escalation in Patients with Refractory or Relapsing MM
Drug
Weekly: patients will receive intravenous infusion of MT-0169 every 7 days on Days 1, 8, 15, and 22 in a 28- days treatment cycle with planned dose levels of 50 mcg/kg, 100 mcg/kg, 200 mcg/kg, 335 mcg/kg, 500 mcg/kg, and 665 mcg/kg. Biweekly: Each cohort will receive intravenous infusion of MT-0169 every 14 days on Days 1 and 15 in a 28- days treatment cycle with escalating doses starting from the MTD/RP2D that will be determined in the weekly dose escalation cohort. 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. Additionally, the investigator and sponsor review of available safety, PK, pharmacodynamics, and efficacy data in the previous cohorts will also be factored in the decision.
Part 2 Biweekly: Dose Expansion in Patients with Refractory or Relapsing NHL
Drug
This cohort will receive biweekly intravenous infusion of MT-0169 every 14 days on Days 1 and 15 in a 28- days treatment cycle. A patient with NHL will start at the highest 'cleared' biweekly dose (i.e., dose deemed sufficiently safe in the Part 1 dose escalation in patients with RRMM) at the time of enrolment.
Part 2: Dose Expansion in patients with RRNHL: Weekly Dosing
Drug
This cohort will receive intravenous infusion of MT-0169 every 7 days on Days 1, 8, 15, and 22 in a 28- days treatment cycle. The dose administered will be the MTD/RP2D in the Weekly Dose Escalation of Part 1.
Part 2: Dose Expansion in Patients with Refractory or Relapsing MM, Anti-CD38 Therapy Naive
Drug
This cohort will receive weekly intravenous infusion of MT-0169 every 7 days on Days 1, 8, 15, and 22 in a 28- days treatment cycle. The dose administered will be the MTD/RP2D in the Weekly Dose Escalation of Part 1.
Part 2: Dose Expansion in patients with RRNHL: Every 2 Weeks
Drug
This cohort will receive intravenous infusion of MT-0169 every 14 days on Days 1 and 15 in a 28- days treatment cycle. The dose administered will be the MTD/RP2D in the Biweekly Dose Escalation of Part 1.
Part 2: Dose Expansion in Patients with RRMM who are Anti-CD38 Therapy naïve: Weekly Dosing
Drug
This cohort will receive intravenous infusion of MT-0169 every 7 days on Days 1, 8, 15, and 22 in a 28- days treatment cycle. The dose administered will be the MTD/RP2D in the Weekly Dose Escalation of Part 1.
Part 2: Dose Expansion in Patients with RRMM who are also Daratumumab RR: Weekly Dosing
Drug
This cohort will receive intravenous infusion of MT-0169 every 7 days on Days 1, 8, 15, and 22 in a 28- days treatment cycle. The dose administered will be the MTD/RP2D in the Weekly Dose Escalation of Part 1.
Part 2 Weekly: Dose Expansion in Patients with Refractory or Relapsing MM, Daratumumab RR
Drug
This cohort will receive weekly intravenous infusion of MT-0169 every 7 days on Days 1, 8, 15, and 22 in a 28- days treatment cycle. The dose administered will be the MTD/RP2D in the Weekly Dose Escalation of Part 1.
Part 2 Weekly: Dose Expansion in Patients with Refractory or Relapsing NHL
Drug
This cohort will receive weekly intravenous infusion of MT-0169 every 7 days on Days 1, 8, 15, and 22 in a 28- days treatment cycle. A patient with NHL will start at the highest 'cleared' weekly dose (i.e., dose deemed sufficiently safe in the Part 1 dose escalation in patients with RRMM) at the time of enrolment.
Part 2 Biweekly: Dose Expansion in Patients with Refractory or Relapsing MM, Daratumumab RR
Drug
This cohort will receive biweekly intravenous infusion of MT-0169 every 14 days on Days 1 and 15 in a 28- days treatment cycle. The dose administered will be the MTD/RP2D in the Biweekly Dose Escalation of Part 1.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 months for reporting.

Closest Location

Miami University - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Inclusion Criteria Part 1 (RRMM patients only)
Confirmed diagnosis of MM per the 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 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 an anti-CD38 therapy is permitted)
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.
Bone marrow (BM) aspirate/biopsy with plasma cell percentage ≥30%
PET imaging with ≥1 plasmacytoma lesion with a single diameter of ≥2cm.

Patient Q&A Section

What causes multiple myeloma?

"In most cases, multiple myeloma arises from a single monoclonal clonal cell of B cell phenotype and origin, a precursor-differentiated B cell (plasmablasts or plasma cells). The exact cell-origin or pathogenetically abnormal circumstances are not known. The risk factors for developing multiple myeloma (including exposure to ionizing radiation, chronic inflammation and aging) are well established." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"Common treatment options for multiple myeloma include the administration of bortezomib, lenalidomide, dexamethasone and high dose melphalan. Another common treatment is the administration of a proteasome inhibitor such as carfilzomib or ixabepilone. Other treatments are radiotherapy or transplantation. There is no cure for multiple myeloma, so treatment is focused on controlling symptoms and prolonging survival." - Anonymous Online Contributor

Unverified Answer

How many people get multiple myeloma a year in the United States?

"Many people in the USA get multiple myeloma, but most people do not realize it is a serious illness that can have serious long-term effects on people's health. This report indicates that there are many people getting multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"Patients with multiple myeloma can achieve a 20- to 30-year survival, which equals or exceeds the 20- to 25-year survival for patients with normal plasma protein levels. However, most patients with multiple myeloma may become symptomatic even on the normal level." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"Myeloma often first presents with nonspecific symptoms such as fatigue/loss of appetite. Other signs may include anemia and weight loss, which may precede pain and a raised level of serum protein in the blood. Bone lesions in advanced disease often cause back pain, which is the initial presenting symptom in about half of cases. A change in bowel habit such as bleeding in the stool or vomiting blood is another feature of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) in the non-plasma cell stage of disease." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"There is a large amount of information available on the internet pertaining to multiple myeloma from health-care providers, medical research groups, patient support groups, and on the internet. Results from a recent paper of the current study showed that general information was the largest source of information about multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Is mt-0169 safe for people?

"The most common side-effects experienced by the women in our study were transient, mild, and transient nausea, nausea and fatigue, and occasional hair loss and dry scalp at the nape, but these were minimal. Patients should not experience more than a common side-effect and be aware of this during discussions on consent and consent forms and documentation. Patients should be cautious about use in those with a history of allergies. The other side effects observed, such as dizziness, chest tightness, chest pains, breathlessness and difficulty breathing, were transient, and did not seem more than a mild inconvenience. Patients should not experience other side effects which they have experienced before, such as rash, swelling, headache and/or diarrhoea." - Anonymous Online Contributor

Unverified Answer

Is mt-0169 typically used in combination with any other treatments?

"In Japan, most multiple myeloma patients are treated as one group with chemotherapy and radiotherapy. mt-0169 is used in combination with any other treatments and the median time to progression is 4.9 months." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of mt-0169?

"Itraconazole, itrudim, and amiodarone induce hepatotoxicity, and the cumulative use of these three drugs is associated with rhabdomyolysis in multiple myeloma patients. The common use of itraconazole does not result in any side effects." - Anonymous Online Contributor

Unverified Answer

How serious can multiple myeloma be?

"More than 30% of patients with MM will not die of the disease within the 5 yr following diagnosis. It is unclear whether disease or treatment related causes were at play. Because more intensive and earlier therapy has not led to a survival benefit for patients with MM in more recent years, it may be necessary to rethink the role of chemotherapy in the treatment of patients with MM." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets multiple myeloma?

"Nearly 80% of patients with multiple myeloma get the disease under the age of 50 years. However, there have not been any studies to determine what percentage of patients under the age of 40 get multiple myeloma. However, a study conducted by the American Cancer Society suggests that 1 in 18,900 people (0.05%) get multiple myeloma at age 20-39 years. When calculating the average age of someone develops multiple myeloma, you must take the age of everyone that goes to that hospital in the past year. So the average age someone develops the disease is 2 years after getting admitted to a hospital for any reason, not from bone marrow cancer." - Anonymous Online Contributor

Unverified Answer

Does multiple myeloma run in families?

"In this large multiethnic [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) family-based study, we do not observe an increased risk of familial multiple myeloma or an increased risk of new occurrence of myeloma with no family history of multiple myeloma. In the future, confirmation of these results will be strengthened by combining these results with those from other studies on familial myeloma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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