Trial · NCT05896228
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of MRD-negativity: Iber-KDd Combination therapy. | Up to 8 months | The rate of minimal residual disease negativity (MRD-negativity) will be reported as the number of participants achieving MRD-negativity after eight cycles of Iber-KDd combination therapy. MRD-negativity is defined as less than one (\<1) residual cancer cell detected in 100,000 cells assessed. |
| Secondary | Number of Participants Experiencing Treatment-Related Toxicity After Starting Iber-KDd Combination Therapy | Up to 9 months | The safety and tolerability of Iber-KDd combination therapy will be assessed and reported as the number of participants experiencing treatment-related toxicity after start of combination therapy, including treatment-related adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion. |
| Secondary | Best Response: Iber-KDd Combination Therapy | Up to 8 months | Best response will be reported as the proportion of participants achieving their greatest response to Iber-KDd combination therapy as follows: Partial response (PR) or better, very good partial response (VGPR) or better, complete response (CR), and stringent complete response (sCR). Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. |
| Secondary | Overall Response Rate (ORR): Iber-KDd Combination Therapy | Up to 8 months | Overall response rate (ORR) is defined as the number of participants achieving partial response (PR), very good partial response (VGFR)m complete response (CR) or stringent complete response (sCR) to Iber-KDd combination therapy. Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. |
| Secondary | Best Response: Iber Monotherapy | Up to 20 months | Best response will be reported as the proportion of participants achieving their greatest response to Iberdomide monotherapy as follows: Partial response (PR) or better, very good partial response (VGPR) or better, complete response (CR), and stringent complete response (sCR). Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. |
| Secondary | Overall Response Rate (ORR): Iber Monotherapy | Up to 20 months | Overall response rate (ORR) is defined as the number of participants achieving partial response (PR), very good partial response (VGFR)m complete response (CR) or stringent complete response (sCR) to Iberdomide monotherapy. Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. |
| Secondary | Duration of Response (DOR): Iber-KDd Combination Therapy | Up to 8 months | Duration of Response (DOR) to Iber-KDd combination therapy will be assessed. Duration of response (DOR) is defined as time from response to progression of disease or death, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 5 years | Overall survival (OS) is defined as the time from date of first dose of study treatment to death from any cause. |
| Secondary | Progression-Free Survival (PFS) | Up to 5 years | Progression-free survival (PFS) is defined as time from date of first dose of study treatment to time of progression or death, whichever occurs first. |
| Secondary | Event-Free Survival (EFS) | Up to 5 years | Event-free survival (EFS) is defined as time from date of first dose of study treatment until 1) toxicity requiring removal from study, 2) progression, or 3) death, whichever occurs first. |
| Secondary | Rate of Sustained MRD-negativity. | Up to 20 months | The rate of sustained minimal residual disease negativity (MRD-negativity) at the completion combination Iber-KDd therapy and 12 cycles of iberdomide monotherapy will be assessed. MRD-negativity is defined as less than one (\<1) residual cancer cell detected in 100,000 cells assessed. The number of participants will sustained Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. |
| Secondary | Rate of MRD-negativity: Iberdomide monotherapy. | Up to 20 months | The rate of MRD-negativity as best response will be assessed among participants completing Iberdomide monotherapy. The number of participants with MRD-negativity at the 10\^-5 sensitivity will be reported. MRD-negativity is defined as less than one (\<1) residual cancer cell detected in 100,000 cells assessed. Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. |
| Secondary | Number of Participants Experiencing Treatment-Related Toxicity After Starting Iberdomide Monotherapy | Up to 21 months | The safety and tolerability of Iber monotherapy will be assessed and reported as the number of participants experiencing treatment-related toxicity after start of monotherapy, including treatment-related adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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