Multiple MyelomaPhase 1NCT02426723
Clinical Study of CWP232291 in Relapsed or Refractory Myeloma Patients
A Phase 1 study testing Phase 1a: CWP232291 and Phase 1b: CWP232291, Lenalidomide, Dexamethasone in people with Multiple Myeloma, run by JW Pharmaceutical at 4 sites in 2 countries.
Trial summary
This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or refractory MM: Phase 1a: single agent CWP232291. Dose-finding followed by cohort expansion at the maximum tolerated dose (MTD) or optimal dose as determined by the Safety Review Committee (SRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Phase 1a: CWP232291 and Phase 1b: CWP232291, Lenalidomide, Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 19 Oct 2015to 26 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and then sign an informed consent form (ICF) prior to initiation of any study-specific procedure and treatment.
- ≥ 18 years of age.
- Confirmed measurable MM based on the following:
- Serum M component (≥ 0.5 g/dL), or
- Urine M protein ≥ 200 mg/24 hours), or
- Serum immunoglobulin free light chains ≥ 10 mg/dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio), or
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- Non-secretory disease measurable with bone marrow biopsy or radiography.
- Failed 2 or more prior standard MM therapies, and >100 days post autologous bone marrow transplant prior to first dose for transplanted subjects. Prior lenalidomide is permitted.
- In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be ≥ 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. Persistent clinically significant toxicities from prior chemotherapy or radiotherapy must not be greater than Grade 1.
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2 (Appendix 3).
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1000/mm3, independent of growth factor support;
- Platelet count ≥ 75,000/mm3;
- Hb ≥ 9 g/dL (independent of transfusions or erythropoiesis-stimulating agents [ESA]).
- Adequate renal function:
- Serum creatinine ≤ 2.5 mg/dL;
- Creatinine clearance (CrCl) ≥ 60 mL/minute (Cockcroft-Gault).
- Adequate hepatic function:
- Total bilirubin < 2.5 x upper limit of normal (ULN); direct bilirubin < 2 x ULN for Gilbert's syndrome;
- Alkaline phosphatase (AP) ≤ 2.5 x ULN, unless considered due to organ leukemic involvement;
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x ULN.
- 11. Women of child-bearing potential (ie, women who are premenopausal or not surgically sterile):
- Two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 4 weeks after discontinuing study drugs, and
- Negative serum or urine pregnancy tests during screening and then within 3 days prior to Day 1. 12. Sexually active men - effective contraceptive methods in subject and partner from the time of informed consent and until ≥ 4 weeks after discontinuing study drugs. 13. Able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Chemotherapy or immunotherapy < 5 half-lives prior to screening.
- Not recovered to Grade 1 from adverse effects of prior myeloma therapy or radiotherapy prior to screening.
- Systemic corticosteroids < 1 week prior to Day 1 in Phase 1a. Subjects may receive stable physiologic replacement doses of glucocorticoids (up to the equivalent of 10 mg daily prednisone) as maintenance therapy for adrenal insufficiency.
- Uncontrolled intercurrent illness including infections and psychiatric illness/social situations that may limit compliance with protocol requirements or the evaluation of study drugs.
- Active cardiovascular disease including myocardial infarction (MI) < 6 months of screening, symptomatic coronary artery disease (CAD), arrhythmias, hypertension, or heart failure not controlled by medication.
- History of deep venous thrombosis and pulmonary embolism (Phase 1b).
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- Anticoagulants < 7 days prior to Day 1. Aspirin is permitted in Phase 1b per standard of care with lenalidomide-based therapy.
- Active central nervous system (CNS) disease.
- Known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C.
- Pregnant or nursing women.
- History of hypersensitivity to lenalidomide (Part B only)
- History of other active malignancies < 3 years prior to screening except basal cell carcinoma, low grade Gleason score ≤ 6 prostate cancer that has been removed with undetectable prostate-specific antigen (PSA), and in situ cervical carcinoma.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
South Korea3 sites
Seoul National University Hospital
Seoul
Seoul St.Mary's Hospital
Seoul
Yonsei Severance Hospital
Seoul
United States1 site
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1a/1b Multicenter, Open Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CWP232291 Administered Intravenously Either Alone or in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Myeloma (MM)
This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or refractory MM:
- Phase 1a: single agent CWP232291. Dose-finding followed by cohort expansion at the maximum tolerated dose (MTD) or optimal dose as determined by the Safety Review Committee (SRC).
- Phase 1b: CWP232291 in combination with lenalidomide and dexamethasone. Dose-finding followed by cohort expansion at the combination therapy MTD or optimal dose as determined by the SRC.
- Conditions
- Multiple Myeloma
- Being tested
- Phase 1a: CWP232291, Phase 1b: CWP232291, Lenalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1a: CWP232291Drug
CWP232291 administered alone twice weekly every 4 weeks.
Phase 1b: CWP232291, Lenalidomide, DexamethasoneDrug
CWP232291 administered twice weekly every 4 weeks. Lenalidomide and Dexamethasone administered per standard therapy.
| Study group | Role | What they receive |
|---|---|---|
| CWP232291 | Experimental | Phase 1a: single administration of CWP232291 ,
Phase 1b: CWP232291 combination with Lenalidomide and Dexamethasone Receives: Drug: Phase 1a: CWP232291; Drug: Phase 1b: CWP232291, Lenalidomide, Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose of Phase 2 trial of CWP232291
Measured: up to 4 weeks
Secondary outcomes (4)
Cmax as a pharmacokinetic parameter of 'CWP232291'
Peak plasma concentration(Cmax) of 'CWP232291'
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
AUC as a pharmacokinetic parameter of 'CWP232291'
Area under the plasma concentration versus time curve (AUC) of 'CWP232291'
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
Cmax as a pharmacokinetic parameter of metabolites of ' CWP232204'
Peak Plasma Concentration (Cmax) of metabolites of 'CWP232291'
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
AUC as a pharmacokinetic parameter of metabolites of ' CWP232204'
Area under the plasma concentration versus time curve (AUC) of metabolites of 'CWP232291'
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start19 Oct 2015
- Primary completion8 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Ki Min, MD, Principal investigator, Seoul St. Mary's HospitalSung-Soo Yoon, MD, Principal investigator, Seoul National University HospitalJin Seok Kim, MD, Principal investigator, Severance HospitalElisabet Manasanch, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426723
- Sponsor's protocol ID
- JW-231MM-102
- Status last verified
- May 2019
- First submitted
- 13 Apr 2015
- Last updated
- 17 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Multicenter, Open Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CWP232291 Administered Intravenously Either Alone or in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Myeloma (MM)
- ClinicalTrials.gov ID
- NCT02426723
- Acronym / sponsor ID
- JW-231MM-102
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or refractory MM:
- Phase 1a: single agent CWP232291. Dose-finding followed by cohort expansion at the maximum tolerated dose (MTD) or optimal dose as determined by the Safety Review Committee (SRC).
- Phase 1b: CWP232291 in combination with lenalidomide and dexamethasone. Dose-finding followed by cohort expansion at the combination therapy MTD or optimal dose as determined by the SRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CWP232291 | Experimental | Drug: Phase 1a: CWP232291, Drug: Phase 1b: CWP232291, Lenalidomide, DexamethasonePhase 1a: single administration of CWP232291 , Phase 1b: CWP232291 combination with Lenalidomide and Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Able to understand and then sign an informed consent form (ICF) prior to initiation of any study-specific procedure and treatment.
- ≥ 18 years of age.
- Confirmed measurable MM based on the following:
- Failed 2 or more prior standard MM therapies, and >100 days post autologous bone marrow transplant prior to first dose for transplanted subjects. Prior lenalidomide is permitted.
- In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be ≥ 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. Persistent clinically significant toxicities from prior chemotherapy or radiotherapy must not be greater than Grade 1.
Key exclusion criteria (12 listed)
- Chemotherapy or immunotherapy < 5 half-lives prior to screening.
- Not recovered to Grade 1 from adverse effects of prior myeloma therapy or radiotherapy prior to screening.
- Systemic corticosteroids < 1 week prior to Day 1 in Phase 1a. Subjects may receive stable physiologic replacement doses of glucocorticoids (up to the equivalent of 10 mg daily prednisone) as maintenance therapy for adrenal insufficiency.
- Uncontrolled intercurrent illness including infections and psychiatric illness/social situations that may limit compliance with protocol requirements or the evaluation of study drugs.
- Active cardiovascular disease including myocardial infarction (MI) < 6 months of screening, symptomatic coronary artery disease (CAD), arrhythmias, hypertension, or heart failure not controlled by medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase 1a: CWP232291CWP232291 administered alone twice weekly every 4 weeks. | Drug | CWP232291 |
| Phase 1b: CWP232291, Lenalidomide, DexamethasoneCWP232291 administered twice weekly every 4 weeks. Lenalidomide and Dexamethasone administered per standard therapy. | Drug | CWP232291 |
Primary outcome
Recommended dose of Phase 2 trial of CWP232291
Time frame: up to 4 weeks
4 secondary outcomes
Cmax as a pharmacokinetic parameter of 'CWP232291'
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
AUC as a pharmacokinetic parameter of 'CWP232291'
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
Cmax as a pharmacokinetic parameter of metabolites of ' CWP232204'
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
AUC as a pharmacokinetic parameter of metabolites of ' CWP232204'
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Ki Min, MD principal investigator
Seoul St. Mary's Hospital
Sung-Soo Yoon, MD principal investigator
Seoul National University Hospital
Jin Seok Kim, MD principal investigator
Severance Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phase 1a: CWP232291 and Phase 1b: CWP232291, Lenalidomide, Dexamethasone in people with Multiple Myeloma, run by JW Pharmaceutical at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended dose of Phase 2 trial of CWP232291 (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.