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New treatment option for Multiple Myeloma (MM)
Official title A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies
ClinicalTrials.gov ID: NCT05908409
What this study is testing
What is IDP-121?
IDP-121 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for multiple myeloma (mm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main aims of this 2-part study are: Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH) and HGBL-NOS, and chronic lymphocytic leukemia (CLL). Phase II: To evaluate the overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), event-free survival (EFS) and Overall survival (OS), in patients with MM, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose (RP2D).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Performance status (ECOG) ≤ 2
- Life expectancy ≥3 months
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the...
You likely can't join if
- Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade \<2...
- Pregnant or lactating women; men and women of reproductive potential\ (as defined in the Appendix 2) who are not using effective contraceptive...
- History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site)
- History of clinically significant hypotension.
- History of clinically significant allergic or hyper-sensitivity reactions.
- History or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including...
See the full eligibility criteria
- Age ≥18 years
- Performance status (ECOG) ≤ 2
- Life expectancy ≥3 months
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time...
- Patients diagnosed with chronic lymphocytic leukemia (CLL), B-cell lymphomas, and multiple myeloma (MM) who are ineligible to reveive the available treatments.
- Adequate hematological or biochemical parameters as specified below
- Hemoglobin \> 8.0 g/dl (without transfusion support within 7 days)
- Platelets count \> 75 x109/L (without transfusional support within 7 days). In patients with bone marrow infiltration, the platelets count may be ≥50 x109/L.
- Absolute neutrophil count (ANC) \> 0.75 x109/L (without G-CSF support within 7 days)
- Aspartate transaminase (AST): \<2.5 x the upper limit range (in patients with no liver metastases or \<5 x ULN in patients with liver metastases)
- Alanine transaminase (ALT): \< 2.5 x the upper limit range (in patients with no liver metastases or \<5 x ULN in patients with liver metastases)
- Total bilirubin: \< 2 x the upper limit range.
- Calculated or measured creatinine clearance: \>30 mL/min (calculated from the Cockcroft-Gault formula).
- Left ventricular ejection fraction \> 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram.
- Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade \<2 symptomatic peripheral neuropathy is allowed.
- Pregnant or lactating women; men and women of reproductive potential\ (as defined in the Appendix 2) who are not using effective contraceptive methods (combined hormonal contraception associated with inhibition of...
- History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site)
- History of clinically significant hypotension.
- History of clinically significant allergic or hyper-sensitivity reactions.
- History or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including (but not limited to):
- Thromboembolism
- Peripheral arterial disease
- Vasculitis
- Other relevant diseases or adverse clinical conditions:
- Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
- Uncontrolled arterial hypertension or cardiac arrhythmias (i.e., requiring a change in medication within the last 3 months or hospital admission within the past 6 months).
- History of significant neurological or psychiatric disorders
- Clinically significant or active infection.
- Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)
- The patient is known to be human immunodeficiency virus (HIV) positive, unless the patient is on antiviral therapy with HIV RNA levels \<50 copies/mL; Hepatitis B surface antigen-positive or active hepatitis C...
- Concomitant anti-tumor therapy within 14 days prior to Day 1 of Cycle 1.
- Prior allogeneic transplantation in the last 3 months or currently active GVHD with immunosuppressive treatment
- Limitation of the patient's ability to comply with the treatment or follow-up protocol.
- If a COVID-19 vaccine is administered, it should be done \>72 hours prior to study treatment initiation or after the completion of the dose-limiting toxicity (DLT) period (if patient is participating in the...
The study team makes the final eligibility decision.
Where it's taking place
- Santander, Cantabria, Spain
- Salamanca, Castille and León, Spain
- Barcelona, Spain
- Madrid, Spain
- Murcia, Spain
- Seville, Spain
- Valencia, Spain
- Zaragoza, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santander, Cantabria, Spain; Salamanca, Castille and León, Spain; Barcelona, Spain; Madrid, Spain; Murcia, Spain; Seville, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.