PHASE II STUDY OF IBERDOMIDE (CC220) MAINTENANCE AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENT
- Conditions
- Kahler's diseaseMM10035227
- Registration Number
- NL-OMON56318
- Lead Sponsor
- Stichting European Myeloma Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
• Subjects with newly diagnosed MM, requiring therapy due to the presence of
CRAB symptoms or myeloma defining events and measurable disease (sPEP >=0.5 g/dL
and/or uPEP >= 200 mg/24h and/or FLC involved >= 10 mg/dL with abnormal FLC
ratio) before induction therapy with a PI and IMID-containing regimen-
• Subjects with complete baseline evaluation at the time of diagnosis according
to revised International Staging System (R-ISS) (cytogenetic profile, ISS and
LDH)
• Subjects treated with proteasome inhibitor plus immunomodulatory drug-based
induction (3-6 cycles), followed by single or double autologous stem cell
transplant (ASCT) with melphalan as condItioning regimen +/- consolidation.
• Subjects within 15 months from diagnosis and 120 days after last ASCT or
consolidation treatment, if performed, who achieved at least a partial response
(PR) after ASCT, according to IMWG criteria
• Subjects willing and able to follow the trial procedures
• Subjects must understand and voluntary sign an ICF prior to any study related
assessment/procedurs being conducted
• Age >=18 years
• ECOG performance status 0-1
• A female of childbearing potential (FCBP) is a female who: 1) has achieved
menarche at some point, 2) has not undergone a hysterectomy or bilateral
oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following
cancer therapy does not rule out childbearing potential) for at least 24
consecutive months (i.e., has had menses at any time in the preceding 24
consecutive months) and must:
a. Have two negative pregnancy tests as verified by the Investigator prior to
starting study treatment. She must agree to ongoing pregnancy testing during
the course of the study, and after end of study treatment. This applies even if
the subject practices true abstinence* from heterosexual contact.
b. Either commit to true abstinence* from heterosexual contact (which must be
reviewed on a monthly basis and source documented) or agree to use, and be able
to comply with two forms of contraception: one highly effective, and one
additional effective (barrier) measure of contraception without interruption 28
days prior to starting investigational product, during the study treatment
(including dose interruptions), and for at least 28 days after the last dose of
CC-220. Contraception requirements are detailed in Appendix H.
• Male subjects must:
a. Practice true abstinence* (which must be reviewed on a monthly basis and
source documented) or agree to use a condom during sexual contact with a
pregnant female or a female of childbearing potential while participating in
the study, during dose interruptions and for at least 90 days following the
last dose of study treatment, even if he has undergone a successful vasectomy.
* True abstinence is acceptable when this is in line with the preferred and
usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not acceptable
methods of contraception.]
• 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 fo
• Systemic AL amyloidosis or plasma cell leukemia (>2.0x109/L circulating
plasma cells by standard differential) or Waldenstrom*s macroglobulinemia
• Subject has known meningeal involvement of multiple myeloma
• History of active malignancy during the past 5 years, except squamous cell
and basal cell carcinomas of the skin and carcinoma in situ of the cervix or
breast and incidental histologic finding of prostate cancer (T1a or T1b using
the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer
that is cured, or malignancy that in the opinion of the local investigator,
with concurrence with the principal investigator, is considered cured with
minimal risk of recurrence within 3 years.
• Subject with any one of the following: clinically significant abnormal
electrocardiogram (ECG) findings at screening; congestive heart failure (New
York Heart Association Class III or IV); myocardial infarction within 12 months
prior to starting iberdomide; unstable or poorly controlled angina pectoris,
including Prinzmetal variant; clinically significant pericardial disease
• Peripheral neuropathy of >=grade 2.
• Subject has any concurrent severe and/or uncontrolled medical condition or
psychiatric disease that is likely to interfere with study procedures or
results, or that in the opinion of the investigator would constitute a hazard
for participating in this study or that confounds the ability to interpret data
from the study.
• Subjects with gastrointestinal disease that may significantly alter the
absorption of iberdomide
• Subject with known history of anaphylaxis or hypersensitivity to thalidomide,
lenalidomide, pomalidomide
• Subject with known or suspected hypersensitivity to excipients contained in
the formulation of iberdomide
• Subjects has current or prior use of immunosuppressive medication within 14
days prior to starting therapy with iberdomide (exceptions are intranasal,
inhaled, topical or local steroids injections; systemic corticosteroids at
doses not exceeding 10 mg/day of prednisone or equivalent; steroids as
premedication for hypersensitivity reactions)
• Subject has taken a strong inhibitor or inducer of CYP3A4/5 including
grapefruit, St John*s wort or related products within 2 weeks prior to dosing
and during the course of study
• Subject known to test positive for HIV or have active hepatitis A, B or C
• Subjects 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
• Baseline lab values:
- Creatinine clearance <=30 ml/min.
- Significant hepatic dysfunction (total bilirubin > 1.5x ULN or AST/ALT > 2.5x
ULN), or > 3.0 mg/dL for subjects with documented Gilbert*s syndrome unless
related to myeloma
- Corrected serum calcium>13.5 mg/dL (3.4 mmol/L)
• Any clinical condition at screening that would preclude subject from
completing the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Response improvement rate within 6 months will be measured as the number of<br /><br>subjects that improve response according to IMWG criteria (from PR to >=VGPR;<br /><br>from VGPR to >=CR; from CR to >sCR) within the end of sixth cycle of treatment.<br /><br><br /><br>Dose reductions/discontinuation rate within 6 months will be measured as the<br /><br>number of subjects that discontinued treatment or have a dose modification<br /><br>within the end of sixth cycle of treatment. </p><br>
- Secondary Outcome Measures
Name Time Method