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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2
Male or female aged ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will study the effects of HDP-101 in patients with multiple myeloma and other plasma cell disorders.
Who is the study for?
This trial is for adults over 18 with relapsed or refractory multiple myeloma who have tried other treatments including immunomodulatory drugs, proteasome inhibitors, and anti-CD38 therapy. They should not be eligible for a stem cell transplant or must have already had one. Participants need to be in relatively stable health (ECOG PS 0-2) and cannot join if they've recently received certain cancer therapies, have active infections like hepatitis B/C or HIV, heart failure, or any other active cancers.Check my eligibility
What is being tested?
The study is testing HDP-101's safety and effectiveness in patients with multiple myeloma. It will look at how the body processes the drug (pharmacokinetics), its tolerability at different doses, and its potential as a treatment option compared to current standards.See study design
What are the potential side effects?
While specific side effects of HDP-101 are not listed here, common side effects from similar treatments include nausea, fatigue, infusion reactions (like fever or chills), blood count changes that can increase infection risk, liver issues, kidney problems and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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I have had a stem cell transplant or am not eligible for one.
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I have been diagnosed with active multiple myeloma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol
Objective response rate (ORR)
Secondary outcome measures
Assess the safety and tolerability of HDP-101
To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE)
Trial Design
1Treatment groups
Experimental Treatment
Group I: HDP-101Experimental Treatment1 Intervention
Participants will receive HDP-101 intravenously at one dose every 3 weeks (21 day cycle) until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal.
During the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.
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Who is running the clinical trial?
Heidelberg Pharma AGLead Sponsor
9 Previous Clinical Trials
1,412 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I have not had radiotherapy in the last 21 days.I have tested positive for hepatitis C.My cancer has spread to my brain or spinal cord.I have a history of heart failure.I have an active liver or biliary disease.I have been diagnosed with plasma cell leukemia.I've been treated with specific myeloma drugs and either didn't respond or couldn't tolerate standard treatments.I can take care of myself and am up and about more than half of my waking hours.I had or plan to have a stem cell transplant using my own or donor cells within 12 weeks.You have a disease that can be measured using specific criteria.I have had symptoms of graft versus host disease after a stem cell transplant in the last year.I do not have any other active cancers.I am 18 years old or older.I have not received treatments targeting BCMA before.You have a positive test for hepatitis B.I have had a stem cell transplant or am not eligible for one.You are expected to live for at least 12 more weeks.I have been diagnosed with active multiple myeloma.I am currently taking medication for an active infection.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: HDP-101
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.
Is this research actively seeking participants?
"Affirmative. Records on clinicaltrials.gov unambiguously demonstrate that the medical trial, which was initially unveiled on February 7th 2022, is currently recruiting patients. 78 individuals are required to be recruited from 3 different sites."
Answered by AI
How many research subjects are engaged in this clinical experiment?
"Absolutely, clinicaltrials.gov has data that affirms this trial is actively seeking participants. Originally posted on February 7th 2022 and last updated on March 10th 2022, the study must recruit 78 individuals among 3 sites."
Answered by AI
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