A Phase 2 interventional study of Lenalidomide maintenance in Multiple Myeloma, sponsored by Samsung Medical Center. Status unknown at 1 site in South Korea. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of salvage treatment with carfilzomib/lenalidomide/dexamethasone (KRD) followed by 2nd autologous stem cell transplantation (ASCT) and lenalidomide maintenance in patients with relapsed myeloma after 1st ASCT.
This is a single-arm phase II study to assess the efficacy and safety of KRD followed by 2nd ASCT - lenalidomide maintenance for 18 months in patients with relapsed multiple myeloma after 1st ASCT who are 70 years of age or younger. A total of 58 participants will be recruited. As a re-induction therapy 6 cycles of KRD (K, 27mg/m2, D1,2,8,9,15,16; R, 25 mg, D1-21; D, 40mg weekly, every 28 days) will be administered. If a patient achieves at least partial response, 2nd ASCT + lenalidomide 10mg for 18 months will be proceeded. Study will be continued until disease progression, unacceptable toxicity, or completion of pre-planned schedule. Response will be assessed using the International Myeloma Working Group(IMWG) response criteria and the safety profiles will be described using the NCI-CTCAE v5.0. Participants who discontinue therapy will be followed every 3 months for 3 years if they are on subsequent treatment, disease-free or dead.
3,713 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's planned enrollment of 58 is above the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Measurable disease (+)
Adequate organ function for induction \& ASCT
Exclusion Criteria:
\[KRd #1\~6, Every 4 weeks\] D1, 2, 8, 9, 15,16 Carfilzomib 20mg/m2 + 5% dextrose in water 50 mL over 10 mins (From Cycle1Day8 27mg/m2) D1 - 21 Lenalidomide 25mg P.O. D1, 8, 15, 22 Dexamethasone 40mg IV or PO \[Autologous stem cell transplantation phase\] \[Lenalidomide maintenance phase, Every 4 weeks\] D1-28 Lenalidomide 10 mg
Drug: Lenalidomide maintenance
Lenalidomide maintenance after carfilzomib, lenalidomide, and dexamethasone re-induction followed by the 2nd ASCT.
2-year progression free survival rate
percentage of patients who are disease free or alive at 2-years
Time frame: 2-years after the written consent
Complete response rate after KRd #6
percentage of patients who achieve complete response
Time frame: total 6 cycles (each cycle is 28 days) of induction therapy
Complete response rate after ASCT
percentage of patients who achieve complete response
Time frame: at the time of 2nd ASCT (within 60 days after ASCT)
Overall response rate
percentage of patients who achieve at least partial response
Time frame: assessed for approximately 3 years after administration
Time to response
from the time of written consent to the time of achieving at least partial response
Time frame: assessed for approximately 3 years after administration
Duration of response
from the time of achieving at least partial response to the time of progressive disease
Time frame: assessed for approximately 3 years after administration
Overall survival
from the time of written consent to the time of death or last follow-up
Time frame: assessed for approximately 3 years after administration
Safety of KRd induction therapy, 2nd ASCT, and lenalidomide maintenance therapy
treatment-emergent adverse events
Time frame: assessed for approximately 2 years during administration
Rate of the successful stem cell harvest
percentage of patients who collected cluster of differentiation(CD34+) hematopoietic stem cells \> 2 x 10\^6 cells/kg
Time frame: total 6 cycles (each cycle is 28 days) of induction therapy
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for May 2024, 30 months after the start.
Of 412 non-industry phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 95. This study's planned 30 months is below that.
Counting every sponsor, half of 502 studies reached it within 55 months; a quarter within 35 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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