TriangleNCT03201965 · CITED IN SOURCE DOCUMENTS
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-11-26
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Participants With Overall Complete Hematologic Response (CHR)
Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Overall Survival (OS)
Organ Response Rate (OrRR) at 6 Months: Cardiac Response
Organ Response Rate (OrRR) at 6 Months: Renal Response
Organ Response Rate (OrRR) at 6 Months: Liver Response
Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months
Time to Complete Hematologic Response (CHR)
Time to Cardiac Response
Time to Liver Response
Time to Renal Response
Time to Subsequent Non-cross Resistant Anti-plasma Cell Therapy
Duration of Complete Hematologic Response (CHR)
Hematologic Very Good Partial Response (VGPR) or Better Rate
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance * Measurable disease of amyloid light-chain (AL) amyloidosis as defined by at least one of the following: 1. serum monoclonal (M)-protein greater than or equal (\>=) 0.5 grams/deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation \[IFE\] performed at a central laboratory) 2. serum free light chain greater than or equal to (\>=) 50 milligram/Liter (mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L * One or more organs impacted by AL amyloidosis according to consensus guidelines * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 Exclusion Criteria: * Prior therapy for AL amyloidosis or multiple myeloma including medications that target CD38, with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to randomization * Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, \>= 60 percent (%) plasma cells in the bone marrow, or hypercalcemia * Evidence of significant cardiovascular conditions as specified below: 1. NT-ProBNP \> 8500 nanogram per liter (ng/L) 2. New York Heart Association (NYHA) classification IIIB or IV heart failure 3. Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (eg, prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram \[ECG\] changes) or uncorrected valvular disease and not primarily due to AL amyloid cardiomyopathy 4. Inpatient admission to a hospital for unstable angina or myocardial infarction within the last 6 months prior to first dose or percutaneous cardiac intervention with recent stent within 6 months or coronary artery bypass grafting within 6 months 5. For participants with congestive heart failure, cardiovascular-related hospitalizations within 4 weeks prior to randomization 6. Participants with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular (AV) nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillators \[ICD\] is indicated but not placed (participants who do have a pacemaker/ICD are allowed on study) 7. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \> 500 milliseconds (msec). Participants who have a pacemaker may be included regardless of calculated QTc interval 8. Supine systolic blood pressure \< 90 millimeter of mercury (mmHg), or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of \> 20 mmHg despite medical management (eg, midodrine, fludrocortisones) in the absence of volume depletion * Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted * Known to be seropositive for human immunodeficiency virus (HIV) * Any one of the following: 1. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Participants with resolved infection (ie, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded 2. Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy) * Grade 2 sensory or Grade 1 painful peripheral neuropathy
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive dexamethasone (40 milligrams \[mg\] orally or intravenous \[IV\] dose), followed by cyclophosphamide (300 milligram per meter square \[mg/m\^2\] orally or IV dose), then bortezomib (1.3 mg/m\^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.
- intervention Names
- Drug: Cyclophosphamide
- Drug: Bortezomib
- Drug: Dexamethasone, 40 mg
- label
- CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)
- type
- ACTIVE_COMPARATOR
- description
- Participants will receive dexamethasone (20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m\^2 orally or IV dose weekly) and bortezomib (1.3 mg/m\^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.
- intervention Names
- Drug: Daratumumab
- label
- CyBorD plus Daratumumab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)
- description
- Participants will receive 300 mg/m\^2 of cyclophosphamide as an oral or IV dose.
- name
- Cyclophosphamide
- type
- DRUG
- arm Group Labels
- CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)
- description
- Participants will receive 1.3 mg/m\^2 of bortezomib as an subcutaneous (SC) injection.
- name
- Bortezomib
- type
- DRUG
- arm Group Labels
- CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)
- description
- Participants of CyBorD alone arm will receive 40 mg dexamethasone orally or IV dose. Participants of CyBorD plus daratumumab arm will receive dexamethasone 20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing to make a total of 40 mg.
- name
- Dexamethasone, 40 mg
- type
- DRUG
- arm Group Labels
- CyBorD plus Daratumumab
- description
- Participants will receive 1800 mg of daratumumab subcutaneously.
- name
- Daratumumab
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 416
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. CHR: normalization of free light chain levels and ratio, negative serum, and urine immunofixation. If involved free light chain (iFLC) is less than (\<) upper limit of normal (ULN) and serum and urine Immunofixation electrophoresis (IFE) are negative, then neither a normal uninvolved free light chain (uFLC) level nor a normal free light chain (FLC) ratio are required for complete response (CR).
- measure
- Percentage of Participants With Overall Complete Hematologic Response (CHR)
- time Frame
- Up to 2.4 years
- secondary Outcomes
- description
- MOD-PFS was defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurred first. Per international amyloidosis consensus criteria (IACC), hematologic progression was defined as satisfying any one of the following criteria: 1) From CHR, abnormal free light chain ratio (light chain must be double and \>ULN); 2) From CHR/VGPR/PR, 50 percent (%) increase in serum M-protein to \>0.5 grams per deciliter (g/dL) or 50% increase in urine M-protein to 200 milligrams (mg)/day; 3) free light chain increase of 50% to 100 milligrams (mg)/Liter (L).
- measure
- Major Organ Deterioration Progression-Free Survival (MOD-PFS)
- time Frame
- From date of first randomization (Day -3) upto 6.5 years
- description
- Overall survival (OS) was measured from the date of randomization to the date of the participant's death.
- measure
- Overall Survival (OS)
- time Frame
- From date of first randomization (Day -3) up to 7.1 years
- description
- The Organ Response Rate (OrRR) for heart was defined as the percentage of participants with baseline involvement of the heart who achieved a confirmed organ response in the heart. Cardiac response was defined as as a decrease of \>30% in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and greater than (\>)300 nanogram/Litre (ng/L).
- measure
- Organ Response Rate (OrRR) at 6 Months: Cardiac Response
- time Frame
- Month 6
- description
- The OrRR for kidney was defined as the percentage of participants with baseline involvement of the kidney who achieved a confirmed renal response in the kidney. Renal response was defined as more than equal to (≥) 30% decrease in proteinuria or proteinuria decreased to \<0.5 grams (g)/24 hours in the absence of renal progression.
- measure
- Organ Response Rate (OrRR) at 6 Months: Renal Response
- time Frame
- Month 6
- description
- The OrRR for liver was defined as the percentage of participants with baseline involvement of the liver who achieved a confirmed liver response in the liver. Liver response was defined as 50% decrease in abnormal alkaline phosphatase value.
- measure
- Organ Response Rate (OrRR) at 6 Months: Liver Response
- time Frame
- Month 6
- description
- CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. CHR: normalization of free light chain levels and ratio, negative serum, and urine immunofixation. If involved free light chain is \< ULN and serum and urine IFE are negative, then neither a normal uninvolved free light chain (uFLC) level nor a normal free light chain (FLC) ratio are required for Complete Response (CR).
- measure
- Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months
- time Frame
- Month 6
- description
- Time to CHR was defined as time between the date of randomization and first efficacy evaluation at which the participant has met all criteria for hematologic CR. CHR was primarily defined by negative immunofixation results and normalized free light chain (FLC) parameters.
- measure
- Time to Complete Hematologic Response (CHR)
- time Frame
- From date of first randomization (Day -3) up to 6.5 years
- description
- Time to cardiac response was defined as the time between the date of randomization and the first efficacy evaluation at which the participant had cardiac response.
- measure
- Time to Cardiac Response
- time Frame
- From date of first randomization (Day -3) up to 6.5 years
- description
- Time to liver response was defined as the time between the date of randomization and the first efficacy evaluation at which the participant had liver response.
- measure
- Time to Liver Response
- time Frame
- From date of first randomization (Day -3) up to 6.5 years
- description
- Time to renal response was defined as the time between the date of randomization and the first efficacy evaluation at which the participant had renal response.
- measure
- Time to Renal Response
- time Frame
- From date of first randomization (Day -3) up to 6.5 years
- description
- Time to subsequent non-cross resistant anti-plasma cell therapy was defined as the time from the date of randomization to the start date of subsequent non-cross resistant, anti-plasma cell therapy.
- measure
- Time to Subsequent Non-cross Resistant Anti-plasma Cell Therapy
- time Frame
- From date of first randomization (Day -3) up to 6.5 years
- description
- Duration of CHR was defined as the time between the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive diseased. CHR was primarily defined by negative immunofixation results and normalized FLC parameters.
- measure
- Duration of Complete Hematologic Response (CHR)
- time Frame
- From date of first randomization (Day -3) up to 6.5 years
Full study description
- brief Summary
- The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
- detailed Description
- Participant involved in study for approx. 8 years duration includes Screening Phase (complete clinical evaluation will be done), Treatment Phase (monitoring of adverse events (AEs), laboratory abnormalities and clinical response), Post-Treatment Observation Phase (disease evaluations will be done) and a Long-term Follow-up Phase (Subsequent anticancer treatment, response to subsequent treatment, date of progression and survival status will be obtained every 16 weeks).The primary hypothesis is that daratumumab in combination with CyBorD will improve the overall complete hematological response rate compared to CyBorD alone in AL amyloidosis participants. Safety will be assessed by AEs, laboratory test results, electrocardiogram, vital sign measurements, physical examination, and Eastern Cooperative Oncology Group (ECOG) performance status.
Source references
- references
- citation
- Kastritis E, Palladini G, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Sanchorawala V, Mollee P, Lu J, Schonland SO, Gatt ME, Suzuki K, Kim K, Cibeira MT, Bhutani M, Beksac M, Libby EN, Valent J, Hungria V, Rosenzweig MA, Bumma N, Huart A, Dimopoulos MA, Bhutani D, Waxman A, Goodman S, Zonder JA, Lam S, Song KW, Hansen T, Manier S, Roeloffzen WWH, Jamroziak K, Kwok F, Shimazaki C, Kim JS, Crusoe EQ, Tran N, Wang J, Chen Y, Vasey SY, Schecter JM, Vermeulen J, Comenzo R, Merlini G. Daratumumab-Bortezomib-Cyclophosphamide-Dexamethasone in Newly Diagnosed Amyloidosis: ANDROMEDA Final Survival Analysis. Blood. 2026 May 12:blood.2025032099. doi: 10.1182/blood.2025032099. Online ahead of print.
- pmid
- 42118698
- type
- DERIVED
- citation
- Suzuki K, Wechalekar AD, Kim K, Shimazaki C, Kim JS, Ikezoe T, Min CK, Zhou F, Cai Z, Chen X, Iida S, Katoh N, Fujisaki T, Shin HJ, Tran N, Qin X, Vasey SY, Tromp B, Weiss BM, Comenzo RL, Kastritis E, Lu J. Daratumumab plus bortezomib, cyclophosphamide, and dexamethasone in Asian patients with newly diagnosed AL amyloidosis: subgroup analysis of ANDROMEDA. Ann Hematol. 2023 Apr;102(4):863-876. doi: 10.1007/s00277-023-05090-z. Epub 2023 Mar 2.
- pmid
- 36862168
- type
- DERIVED
- citation
- Minnema MC, Dispenzieri A, Merlini G, Comenzo RL, Kastritis E, Wechalekar AD, Grogan M, Witteles R, Ruberg FL, Maurer MS, Tran N, Qin X, Vasey SY, Weiss BM, Vermeulen J, Jaccard A. Outcomes by Cardiac Stage in Patients With Newly Diagnosed AL Amyloidosis: Phase 3 ANDROMEDA Trial. JACC CardioOncol. 2022 Nov 15;4(4):474-487. doi: 10.1016/j.jaccao.2022.08.011. eCollection 2022 Nov.
- pmid
- 36444227
- type
- DERIVED
- citation
- Kastritis E, Palladini G, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Sanchorawala V, Gibbs S, Mollee P, Venner CP, Lu J, Schonland S, Gatt ME, Suzuki K, Kim K, Cibeira MT, Beksac M, Libby E, Valent J, Hungria V, Wong SW, Rosenzweig M, Bumma N, Huart A, Dimopoulos MA, Bhutani D, Waxman AJ, Goodman SA, Zonder JA, Lam S, Song K, Hansen T, Manier S, Roeloffzen W, Jamroziak K, Kwok F, Shimazaki C, Kim JS, Crusoe E, Ahmadi T, Tran N, Qin X, Vasey SY, Tromp B, Schecter JM, Weiss BM, Zhuang SH, Vermeulen J, Merlini G, Comenzo RL; ANDROMEDA Trial Investigators. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis. N Engl J Med. 2021 Jul 1;385(1):46-58. doi: 10.1056/NEJMoa2028631.
- pmid
- 34192431
- type
- DERIVED
- citation
- Palladini G, Kastritis E, Maurer MS, Zonder J, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Bumma N, Kaufman JL, Medvedova E, Kovacsovics T, Rosenzweig M, Sanchorawala V, Qin X, Vasey SY, Weiss BM, Vermeulen J, Merlini G, Comenzo RL. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood. 2020 Jul 2;136(1):71-80. doi: 10.1182/blood.2019004460.
- pmid
- 32244252
- type
- DERIVED
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- Light Chain Amyloidosis In Combination with Bortezomib, Cyclophosphamide and Dexamethasone The efficacy of DARZALEX FASPRO with VCd was evaluated in ANDROMEDA (NCT03201965), an open-label, randomized, active-controlled trial. Eligible patients were required to have newly diagnosed light chain (AL) amyloidosis with at least one af
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- Darzalex Faspro will be posted on <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a>.</p><p>Efficacy was evaluated in ANDROMEDA (NCT03201965), an open-label, randomized, active-controlled trial in 388 patients with newly diagnosed AL amyloidosis with measurable disease and at least one affected orga
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Preserved source evidence · Not medical advice