BridgeMD
A study to decide what is the highest dose of CC-220 to take alone and with other standard of care treatments to assess the side effects, effectiveness and how the body deals with the drug in patients with multiple myeloma
EU CTIS ID: 2024-510799-19-00
What this study is testing
Part 1 To determine the maximum tolerated doses (MTDs) and/or RP2D of CC- 220 as monotherapy (MonoT), in combination with DEX (DoubleT), in combination with DEX and daratumumab (DARA) (CC-220Dd), in combination with DEX and bortezomib (BTZ) (CC-220Vd), and in combination with DEX and carfilzomib (CFZ) (CC-220Kd) in subjects with RRMM. Part 2 To determine the efficacy of CC-220 in combination with DEX (Double T) in subjects with RRMM in Cohort D, as measured by overall response rate (ORR).
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject is ≥18 years of age at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- Please refer to the protocol page 68 for a discussion on the criteria for a female of childbearing potential.
- Please refer to the protocol page 68 for a discussion on the conditions of practicing true abstinence for male subjects.
- Males must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 90 days following last dose of study treatment.
- All subjects must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment.
You likely can't join if
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide, DEX, daratumumab (for Cohorts E and K), bortezomib (for Cohorts F, J1 and J2) or carfilzomib (for Cohorts G1 and G2). Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC- 220, DEX, daratumumab (for Cohorts E and K), bortezomib (for Cohorts F, J1 and J2) or carfilzomib (for Cohorts G1 and G2).
- Contraindications to the other treatment regimens, as per local prescribing information
- Subject has received any of the following within the last 14 days of initiating IP: ·Plasmapheresis ·Major surgery (as defined by the Investigator) ·Radiation therapy other than local therapy for MM associated bone lesions ·Use of any systemic myeloma drug therapy
- Subject has been treated with an investigational agent (ie, an agent not commercially available) within 28 days or 5 half-lives (whichever is longer) of initiating IP. Not applicable for subjects who had CAR T as last prior regimen.
- Subject has any one of the following: ·Clinically significant abnormal electrocardiogram (ECG) finding at Screening ·Congestive heart failure (New York Heart Association Class III or IV) ·Myocardial infarction within 12 months prior to starting IP ·Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris
See the full eligibility criteria
Who can join
- Subject is ≥18 years of age at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- Please refer to the protocol page 68 for a discussion on the criteria for a female of childbearing potential.
- Please refer to the protocol page 68 for a discussion on the conditions of practicing true abstinence for male subjects.
- Males must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 90 days following last dose of study treatment.
- All subjects must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment.
- All male and female subjects must follow all requirements defined in the Pregnancy Prevention Program. See Appendix D of the protocol for CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials
- Subjects in Cohort D must have received prior treatment with at least 2 consecutive cycles of a glucocorticoid-containing regimen.
- Subjects in Cohort D must be refractory to an ID agent, a proteasome inhibitor, a glucocorticoid and a CD38 antibody.
- Subjects in Cohort I must have received prior treatment with a BCMA targeted therapy.
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements
- All subjects in RRMM cohorts must have a documented diagnosis of MM and have measurable disease defined as: a. M-protein (serum and/or urine protein electrophoresis (sPEP or uPEP)): sPEP ≥0.5 g/dL or uPEP ≥ 200 mg/24 hours and/or b. Light chain MM without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Subjects in Cohorts A,B,C, E, G1 and G2 must have received at least 2 prior myeloma regimens (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen). Subjects in Cohort F must have received at least 1 prior myeloma regimen. Subjects in Cohorts D and I must have received at least 3 prior myeloma regimens.
- All subjects in RRMM cohorts must have received prior treatment with at least 2 consecutive cycles of a lenalidomide or pomalidomidecontaining regimen. Subjects in Cohort D must have received prior treatment with at least 2 consecutive cycles of a lenalidomide-containing regimen and at least 2 consecutive cycles of a pomalidomide-containing regimen.
- All subjects in RRMM cohorts must have received prior treatment with at least 2 consecutive cycles of a proteasome inhibitor or a proteasome inhibitor-containing regimen
- For Part 2 RRMM cohorts (Cohorts C,D,and I) all subjects must have received prior treatment with at least 2 consecutive cycles of a CD38 antibody or a CD38 antibody-containing regimen
- All subjects in RRMM cohorts must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy. Subjects who had CAR T therapy as their last myeloma therapy must have documented disease progression.
What rules you out
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide, DEX, daratumumab (for Cohorts E and K), bortezomib (for Cohorts F, J1 and J2) or carfilzomib (for Cohorts G1 and G2). Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC- 220, DEX, daratumumab (for Cohorts E and K), bortezomib (for Cohorts F, J1 and J2) or carfilzomib (for Cohorts G1 and G2).
- Contraindications to the other treatment regimens, as per local prescribing information
- Subject has received any of the following within the last 14 days of initiating IP: ·Plasmapheresis ·Major surgery (as defined by the Investigator) ·Radiation therapy other than local therapy for MM associated bone lesions ·Use of any systemic myeloma drug therapy
- Subject has been treated with an investigational agent (ie, an agent not commercially available) within 28 days or 5 half-lives (whichever is longer) of initiating IP. Not applicable for subjects who had CAR T as last prior regimen.
- Subject has any one of the following: ·Clinically significant abnormal electrocardiogram (ECG) finding at Screening ·Congestive heart failure (New York Heart Association Class III or IV) ·Myocardial infarction within 12 months prior to starting IP ·Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris
- Subject has current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion: ·Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection) ·Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisone or equivalent ·Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication)
- Subject has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St. John's Wort or related products within two weeks prior to dosing and during the course of study.
- Subject known to test positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis A or C
- Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis
- Subject is a female who is pregnant, nursing or breastfeeding, or who intends to become pregnant during the participation in the study
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Subject has any condition that confounds the ability to interpret data from the study
- Subject has nonsecretory multiple myeloma
- Subjects with Plasma Cell leukemia or amyloidosis
- Any of the following laboratory abnormalities ·Absolute neutrophil count (ANC) <1,000/μL ·Platelet count <75,000/μL for Part 1. For Part 2; platelet count < 75,000/μL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; otherwise platelet count < 50,000/μL(transfusions are not permitted to achieve minimum platelet counts) ·Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) ·Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≥2.0 x upper limit of normal (ULN) ·Serum total bilirubin and alkaline phosphatase >1.5 x ULN ·Subjects with serious renal impairment (creatinine clearance [CrCl] <30 mL/min) or requiring dialysis would be excluded
- Subjects with peripheral neuropathy ≥Grade 2
- Subjects with gastrointestinal disease that may significantly alter the absorption of CC-220
- Subjects with a prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥5 years with the exception of the following noninvasive malignancies: ·Basal cell carcinoma of the skin ·Squamous cell carcinoma of the skin ·Carcinoma in situ of the cervix ·Carcinoma in situ of the breast ·Incidental histological findings of prostate cancer such as T1a or T1b using the Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer that is curative
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Canada
- United Kingdom
- Japan
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Canada; United Kingdom; Japan; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.