Your session is about to expire
← Back to Search
Immunotherapy
Modakafusp Alfa for Multiple Myeloma (iinnovate-2 Trial)
Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior allogeneic hematopoietic stem cell transplant or solid organ transplant
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
iinnovate-2 Trial Summary
This trial is testing a new cancer drug to see what side effects it may cause and what the recommended dose of the drug should be.
Who is the study for?
Adults with Multiple Myeloma who've had a stem cell transplant within the past 12 months and are MRD positive post-transplant. They should have good organ function, an ECOG status of 0-2, and no progression after initial therapy. Excluded are those in other MM trials, treated with modakafusp alfa before, or with certain medical conditions like severe allergies to trial drugs or active hepatitis B/C or HIV.Check my eligibility
What is being tested?
The study is testing modakafusp alfa combined with other myeloma treatments (Carfilzomib, Lenalidomide etc.) to find the highest safe dose. Participants will receive increasing doses of modakafusp alfa through IV until they reach a dose that's effective without harmful side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever or chills, allergic responses to components in the drug mixtures used including skin rashes or breathing difficulties, and general symptoms like fatigue. Organ inflammation could also occur.
iinnovate-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had a bone marrow or organ transplant.
Select...
I am able to care for myself and perform daily activities.
Select...
I have multiple myeloma as diagnosed by standard criteria.
Select...
My cancer is still detectable after stem cell transplant.
iinnovate-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)
Number of Participants With Dose-limiting Toxicities (DLTs)
Secondary outcome measures
Duration of Response (DOR)
Group 1: Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity
Group 1: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5
+12 moreiinnovate-2 Trial Design
6Treatment groups
Experimental Treatment
Group I: Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + PomalidomideExperimental Treatment3 Interventions
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Daratumumab injection subcutaneously on Days 1, 8, 15 and 22 of Cycles 1 and 2, further followed by on Days 1 and 15 of Cycles 3 to 6, thereafter on Day 1 on a 28-day (4-week) treatment cycle along with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Group II: Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + BortezomibExperimental Treatment3 Interventions
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle along with Bortezomib injection subcutaneously on Days 8, 15 and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Group III: Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + CarfilzomibExperimental Treatment2 Interventions
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
This arm is closed for enrollment after 3 participants were enrolled.
Group IV: Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + BortezomibExperimental Treatment2 Interventions
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Bortezomib injection subcutaneously on Days 8, 15, and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Group V: Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + PomalidomideExperimental Treatment2 Interventions
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Group VI: Group 1 (MM Maintenance) Arm 1: Modakafusp alfa + LenalidomideExperimental Treatment2 Interventions
Modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with Lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD [-] negative participants, whichever occurs first. Participants who remain MRD positive with demonstrated clinical benefit after 2 years of maintenance therapy may continue treatment beyond 2 years with agreement of the sponsor/designee.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Bortezomib
2005
Completed Phase 2
~1140
Daratumumab
2014
Completed Phase 3
~1860
Pomalidomide
2011
Completed Phase 2
~1020
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,142 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,113 Patients Enrolled for Multiple Myeloma
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,560 Total Patients Enrolled
25 Trials studying Multiple Myeloma
7,410 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organ functions are within the required range for the study.My heart's electrical cycle is longer than normal.My multiple myeloma has spread to my brain or meninges.I had a stem cell transplant for multiple myeloma within the last 6 months.I have not had a bone marrow or organ transplant.I am able to care for myself and perform daily activities.I have multiple myeloma as diagnosed by standard criteria.I haven't had cancer, except for specific low-risk types, in the last 3 years.You have tested positive for hepatitis B, hepatitis C, or HIV.I take more than 10 mg/dL of prednisone or equivalent for a chronic condition, not including my MM treatment.I am not allergic to any ingredients in the medication or its similar drugs.My multiple myeloma is measurable by medical tests.I have not started lenalidomide maintenance before joining this study.I have recovered from most side effects of my stem cell transplant, except for hair loss and missed periods.My cancer is still detectable after stem cell transplant.I have been diagnosed with a specific blood or bone marrow condition.I have been treated with modakafusp alfa before.I haven't taken strong drugs that affect liver enzymes recently.I haven't worsened after my first treatment and have had no more than 2 treatments before stem cell transplant, excluding dexamethasone alone.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (MM Maintenance) Arm 1: Modakafusp alfa + Lenalidomide
- Group 2: Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + Pomalidomide
- Group 3: Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + Bortezomib
- Group 4: Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib
- Group 5: Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib
- Group 6: Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any long-term risks associated with the combination of Modakafusp alfa and Carfilzomib within Group 2 (RRMM Doublets) Arm 4?
"Given the preliminary stage of clinical trials, our team at Power has evaluated Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib to be relatively safe and given it a score of 1."
Answered by AI
Is this clinical experiment taking place in multiple locations within the state?
"The clinical trial is presently underway at 21 locations, with Iowa City, Toronto and New york being the largest cities in which it can be accessed. To reduce travel stressors for participants, it may be best to select a location close by if one wishes to enroll."
Answered by AI
Are there any available positions in this research endeavor for participants?
"Confirmed, this clinical trial is actively enrolling patients and has been since October 27th 2022 as per the information on clinicaltrials.gov. It was last edited two weeks ago on November 10th of the same year."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger