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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with pathologically confirmed MM who have progressed on or after standard therapy (R/R patients) must have a body weight ≥ 40.0 kg at screening
Patients with pathologically confirmed multiple myeloma (MM) who have progressed on or after standard therapy (relapsed/refractory [R/R] patients) must have received at least 3 prior lines of therapy, including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit. (Note: Patients in Australia may have received any of the therapies including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial will study a new drug, ISB 1442, to see if it is safe and effective in treating multiple myeloma that has returned or does not respond to treatment.
Who is the study for?
Adults over 18 with relapsed/refractory multiple myeloma who've tried at least three prior treatments, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapies. They should weigh at least 40 kg, have a life expectancy of more than 3 months, measurable disease by specific criteria, be able to perform daily activities (ECOG ≤2), and have proper organ function.Check my eligibility
What is being tested?
The trial is testing ISB 1442 SC injection in two forms: escalating doses to find the right amount that's safe and effective (Phase 1) and then giving this dose to more patients to see how well it works (Phase 2). It's for people whose multiple myeloma has come back or didn't respond after standard treatment.See study design
What are the potential side effects?
Possible side effects are not detailed here but may include reactions related to human recombinant proteins or the ingredients in ISB 1442. Patients with severe allergies or anaphylactic reactions to similar compounds were excluded from the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 40 kg and my multiple myeloma has worsened after standard treatment.
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I have multiple myeloma and have tried at least 3 treatments without success.
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My multiple myeloma has worsened after treatment, and tests show it's still active.
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If you have a confirmed diagnosis of multiple myeloma and have not responded well to standard treatments, your liver, kidney, and heart function must meet certain levels to participate in the trial.
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I have MM, have tried standard treatments without success, and can care for myself.
Select...
I have MM and have tried at least 3 treatments including PIs, IMiDs, and anti-CD38.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Phase 1: Number of Dose-Limiting Toxicities (DLTS) During the First 28 Days After the First Administration of ISB 1442 (Cycle 1)
Phase 2: Multiple Myeloma: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Secondary outcome measures
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 1442 in Serum
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB1442 in Serum
Maximum Concentration (Cmax) of ISB 1442 in Serum
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2 (Dose Expansion): Cohort B: R/R MM Post-T-cell-Directed TherapyExperimental Treatment1 Intervention
This cohort includes the participants with pathologically confirmed R/R MM post T cell-directed therapy and have received prior treatment with proteasome inhibitors (PIs), immunomodulators (IMiDs), and anti-CD38 therapies either in combination or as a single agent; and must have failed at least 3 prior lines of treatment. Participants will receive the RP2D of ISB 1442 SC injection determined in Phase 1 of the study. Each treatment cycle duration is 28 days. The anticipated total duration for each participant will vary, depending on the number of cycles of treatment completed. The treatment phase will extend until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met.
Group II: Phase 2 (Dose Expansion): Cohort A: R/R Multiple MyelomaExperimental Treatment1 Intervention
This cohort includes the participants with pathologically confirmed R/R MM and must have received at least 3 prior lines of therapy, including proteasome inhibitors (PIs), immunomodulators (IMiDs), and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit. Participants will receive the recommended Phase 2 Dose (RP2D) of ISB 1442 SC injection determined in Phase 1 of the study for treatment of R/R MM. Each treatment cycle duration is 28 days. The anticipated total duration for each participant will vary, depending on the number of cycles of treatment completed. The treatment phase will extend until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met.
Group III: Phase 1: Dose escalationExperimental Treatment1 Intervention
Participants with R/R multiple myeloma (MM) will be administered ISB 1442 weekly by subcutaneous (SC) injection in each 28-day cycle. Dose escalation will begin with an accelerated titration dose escalation and should certain conversion criteria be met, escalation will convert to the standard (3 + 3) dose escalation
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Who is running the clinical trial?
Ichnos Sciences SALead Sponsor
6 Previous Clinical Trials
888 Total Patients Enrolled
2 Trials studying Multiple Myeloma
325 Patients Enrolled for Multiple Myeloma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh at least 40 kg and my multiple myeloma has worsened after standard treatment.I am 18 years old or older.I have multiple myeloma and have tried at least 3 treatments without success.I haven't had major radiation therapy or to a large part of my bone marrow in the last 14 days.My multiple myeloma has worsened after treatment, and tests show it's still active.I haven't had certain cancer treatments or investigational drugs recently.My body does not respond to blood or platelet transfusions.My cancer has returned, but only shows up on sensitive tests.I have multiple myeloma, it's resistant to treatment, and I'm expected to live at least 3 more months.If you have a confirmed diagnosis of multiple myeloma and have not responded well to standard treatments, your liver, kidney, and heart function must meet certain levels to participate in the trial.I had a stem cell transplant using my own cells within the last 3 months.I have MM, have tried standard treatments without success, and can care for myself.You have had serious allergic reactions to certain proteins or ingredients in the ISB 1442 medication.My multiple myeloma is only measurable by plasmacytoma.My cancer has spread to my brain or spinal cord.Your heart's electrical activity takes longer than usual, measured by a specific method at the screening.I have MM and have tried at least 3 treatments including PIs, IMiDs, and anti-CD38.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 (Dose Expansion): Cohort A: R/R Multiple Myeloma
- Group 2: Phase 1: Dose escalation
- Group 3: Phase 2 (Dose Expansion): Cohort B: R/R MM Post-T-cell-Directed Therapy
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 opportunities to join this medical experiment?
"Affirmative. According to the details listed on clinicaltrials.gov, this research study is still recruiting patients since its inception in September 27th 2022 and latest edit on October 14th 2022. This endeavour requires 121 participants from a single medical centre."
Answered by AI
How many individuals have been recruited for this research program?
"Affirmative. Based on the information posted to clinicaltrials.gov, this medical research project is currently recruiting volunteers. Initially published on September 27th 2022 and last revised October 14th 2022, 121 participants are being sought from a single trial site."
Answered by AI
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