Multiple Myeloma and Other Plasma Cell Neoplasms
Conditions
Keywords
multiple myeloma, myeloma
Brief summary
This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and/or establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and/or RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r/r MM.
Interventions
DRUGHDP-101
HDP-101 is available as lyophilized white powder for preparation of infusion.
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Heidelberg Pharma AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged ≥18 years. * Life expectancy \>12 weeks. * Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2. * A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG). * Must have undergone SCT or is considered transplant ineligible. * Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator. * Measurable disease as per IMWG criteria (Dose-escalation part only: patients with non-secretory or oligo-secretory myeloma (NSMM) not meeting the measurability criteria are eligible). * Adequate organ system function as defined in protocol.
Exclusion criteria
* Known central nervous system involvement. * Plasma cell leukemia. * History of congestive heart failure. * Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT. * Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion. * Radiotherapy within 21 days prior to the first study treatment infusion. * History of any other malignancy known to be active. * Known human immunodeficiency virus infection. * Patients with active infection requiring systemic anti-infective therapy. * Patients with positive hepatitis B virus (HBV) infection or positive hepatitis C virus (HCV) infection. * Current active liver or biliary disease. * Pregnancy or breast feeding. * Pneumonia or symptomatic pneumonitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment. | Up to Day 21 (from first dose) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with serious and non-serious adverse events | Through study completion, an average of 1 year | Incidence and grading of adverse events (AEs) and serious adverse events (SAEs) (based on the National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0). Incidence of treatment interruption and dose adjustment due to AEs and changes in laboratory tests, vital signs, physical examination and electrocardiogram (ECG). |
| Objective response rate (ORR) | Through study completion, an average of 1 year | Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria. |
| Minimal residual disease (MRD) negativity rate | Through study completion, an average of 1 year | Proportion of enrolled subjects who achieve minimal residual disease (MRD) free status, according to the IMWG criteria. |
| Progression-free survival (PFS) | Through study completion, an average of 1 year | PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause, whichever occurs first as determined by the investigator |
| Duration of response (DOR) | Through study completion, an average of 1 year | DOR is defined as the interval from the first documentation of PR or better until disease progression or death due to any cause, whichever occurs first |
| Time to objective response (TOR) | Through study completion, an average of 1 year | TOR is defined as the interval from the start of study therapy to the first documentation of PR or better |
| Overall survival (OS) | Through study completion, an average of 1 year | OS is defined as the time from randomization to death due to any cause |
Countries
China
Contacts
CONTACTJianfei Zhao
Outcome results
None listed