A Phase 2 interventional study of dexamethasone and cisplatin in Extramedullary Plasmacytoma, Isolated Plasmacytoma of Bone and Light Chain Deposition Disease, sponsored by Margarida Magalhaes-Silverman. Completed at 1 site in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by Margarida Magalhaes-Silverman · Phase 2, Interventional, and Treatment
This phase II trial investigates whether patients greater than or equal to 65 years of age diagnosed with myeloma or another plasma cell malignancy will have better outcomes with transplant followed by maintenance therapy, as primarily measured by progression-free survival, versus non-transplant approaches.
PRIMARY OBJECTIVES:
I. To evaluate the progression-free survival (PFS) from the start of dexamethasone, cisplatin, Adriamycin (doxorubicin),Cytoxan (cyclophosphamide), etoposide (DPACE) for all participants who have had at least one day of protocol treatment.
II. To evaluate how well such therapy is tolerated in patients mainly over the age of 65 years by assessing severe complications (intensive care unit [ICU] admission, death) and the percentage of participants able to complete the full course of therapy.
SECONDARY OBJECTIVES:
I. To evaluate Quality-Of-Life post-transplant using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire QLQ-C30 and QLC-MY20.
OUTLINE:
INDUCTION THERAPY: Patients receive dexamethasone orally (PO) on days 1-4 and 8-11, cisplatin intravenously (IV) continuously, doxorubicin hydrochloride IV continuously, cyclophosphamide IV, and etoposide IV on days 1-4. Patients then receive pegfilgrastim subcutaneously (SQ) on days 6 and 13 and undergo collection of stem cells when white blood cell (WBC) and cluster of differentiation (CD)34 counts are within program range. Following stem cell collection, patients may receive interim dexamethasone PO on days 1-4, every 14 days at the discretion of the treating physician.
TRANSPLANT: Beginning between 4 weeks to 6 months after the first day of induction therapy, patients receive as transplant conditioning regimen dexamethasone PO on days -4 to -1 and days +2 through +5, bortezomib IV bolus on days -4, -1, 2, and 5, thalidomide PO on days -4 to 5, and melphalan IV on days -4 and -1. Patients undergo autologous peripheral blood stem cell transplant (PBSCT) on day 0. Between transplant and consolidation therapy, patients receive dexamethasone PO on days 1-4 every 21 days and thalidomide PO daily.
CONSOLIDATION THERAPY: If administered, post-transplant consolidation may begin 4-6 weeks after transplant but should occur no more than 4 months later. Most patients will not receive consolidation. Those that do will receive dexamethasone PO on days 1-4 and 8-11, thalidomide PO on days 1-11, bortezomib IV on days 1, 4, 8, and 11, cisplatin IV continuously, doxorubicin hydrochloride IV continuously, cyclophosphamide IV continuously, and etoposide IV continuously on days 1-4.
MAINTENANCE THERAPY YEAR 1: Beginning 6 weeks-6 months after consolidation therapy or 4 weeks to 6 months after transplant if consolidation is skipped, patients receive bortezomib IV bolus on days 1, 4, 15, and 18, thalidomide PO QD on days 1-28, and dexamethasone PO on days 1-4 and 15-18. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY YEAR 2: Patients receive bortezomib IV on days 1, 4, 15, and 18, cyclophosphamide PO or IV on days 1 and 15, and dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least once annually at the study center, but serum for MM marker results will be sent to the study site for close monitoring of PFS .
239 studies on the registry are indexed under Immunoglobulin Light-chain Amyloidosis; 63 are open to participants now.
This study's enrollment of 41 is close to the median of 39 across 169 interventional studies indexed under Immunoglobulin Light-chain Amyloidosis.
Browse Immunoglobulin Light-chain Amyloidosis studies →This is the only study on the registry with Margarida Magalhaes-Silverman as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
Drug: dexamethasone · Drug: cisplatin · Drug: doxorubicin · Drug: cyclophosphamide · Drug: etoposide · Drug: bortezomib · Drug: thalidomide · Drug: melphalan · Procedure: autologous stem cell transplant
Given PO
Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM
Given IV
Also known as: CACP, CDDP, CPDD, DDP
Given IV
Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Given IV or PO
Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Given IV
Also known as: EPEG, VP-16, VP-16-213
Given IV
Also known as: LDP 341, MLN341, VELCADE
Given PO
Also known as: Kevadon, Synovir, THAL, Thalomid
Given IV
Also known as: Alkeran, CB-3025, L-PAM, L-phenylalanine mustard, L-Sarcolysin
Median Progression Free Survival (mPFS)
PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.
Time frame: From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
Percentage of Participants With Serious Treatment-Related Complications
Percentage of participants with severe complications defined at ICU admission and death, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Time frame: From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
Percentage of Participants Able to Complete Full Course Therapy
Percentage of participants able to complete the full course of therapy.
Time frame: Up to 6 years
Mean Change in Quality-Of-Life Indicators Post-Transplant
Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.
Time frame: Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.
| Milestone | Autologous Stem Cell Transplant |
|---|---|
| Started | 41 |
| Completed | 19 |
| Not completed | 22 |
| Withdrew: Adverse event | 5 |
| Withdrew: Death | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Unable to comply | 2 |
| Withdrew: Disease progression | 11 |
PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.
| months | Autologous Stem Cell Transplant |
|---|---|
| Median Progression Free Survival (mPFS) | 76.4 (43.6 to NA) |
Percentage of participants with severe complications defined at ICU admission and death, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
| Participants | Autologous Stem Cell Transplant |
|---|---|
| Percentage of Participants With Serious Treatment-Related Complications | 4 |
Percentage of participants able to complete the full course of therapy.
| Participants | Autologous Stem Cell Transplant |
|---|---|
| Percentage of Participants Able to Complete Full Course Therapy | 24 |
Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.
| score on a scale | Autologous Stem Cell Transplant |
|---|---|
| Change in Physical Functioning at Pre-Maintenance | 1.3 (-5.2 to 7.9) |
| Change in Physical Functioning at Maintenance Cycle 6 | -0.6 (-7.1 to 5.9) |
| Change in Physical Functioning at Maintenance Cycle 12 | 1.1 (-5.6 to 7.8) |
| Change in Physical Functioning at Maintenance Cycle 18 | 5.4 (-1.5 to 12.3) |
| Change in Physical Functioning at Maintenance Cycle 24 | 4.6 (-2.6 to 11.7) |
| Change in Role Functioning at Pre-Maintenance | 7.4 (-5.5 to 20.4) |
| Change in Role Functioning at Maintenance Cycle 6 | 8.7 (-4.0 to 21.5) |
| Change in Role Functioning at Maintenance Cycle 12 | 4.4 (-8.7 to 17.5) |
| Change in Role Functioning at Maintenance Cycle 18 | 7.0 (-6.6 to 20.5) |
| Change in Role Functioning at Maintenance Cycle 24 | 6.0 (-8.0 to 20.0) |
| Change in Emotional Functioning at Pre-Maintenance | 8.7 (2.5 to 14.9) |
| Change in Emotional Functioning at Maintenance Cycle 6 | 5.5 (-0.6 to 11.6) |
| Change in Emotional Functioning at Maintenance Cycle 12 | 1.4 (-4.9 to 7.7) |
| Change in Emotional Functioning at Maintenance Cycle 18 | 5.8 (-1.0 to 12.5) |
| Change in Emotional Functioning at Maintenance Cycle 24 | 8.3 (1.3 to 15.2) |
| Change in Cognitive Functioning at Pre-Maintenance | 0.4 (-7.1 to 7.9) |
| Change in Cognitive Functioning at Maintenance Cycle 6 | -4.6 (-12.0 to 2.9) |
| Change in Cognitive Functioning at Maintenance Cycle 12 | -5.1 (-12.8 to 2.5) |
| Change in Cognitive Functioning at Maintenance Cycle 18 | -6.0 (-14.0 to 2.1) |
| Change in Cognitive Functioning at Maintenance Cycle 24 | -3.6 (-11.9 to 4.7) |
| Change in Social Functioning at Pre-Maintenance | -1.0 (-11.0 to 9.1) |
| Change in Social Functioning at Maintenance Cycle 6 | 2.7 (-7.2 to 12.6) |
| Change in Social Functioning at Maintenance Cycle 12 | -4.9 (-15.3 to 5.6) |
| Change in Social Functioning at Maintenance Cycle 18 | 0.8 (-9.9 to 11.6) |
| Change in Social Functioning at Maintenance Cycle 24 | -1.5 (-12.7 to 9.7) |
| Change in Global Health Status at Pre-Maintenance | 5.4 (-2.7 to 13.5) |
| Change in Global Health Status at Maintenance Cycle 6 | 0.2 (-7.8 to 8.3) |
| Change in Global Health Status at Maintenance Cycle 12 | -3.1 (-11.4 to 5.1) |
| Change in Global Health Status at Maintenance Cycle 18 | -0.1 (-8.8 to 8.5) |
| Change in Global Health Status at Maintenance Cycle 24 | 3.4 (-5.6 to 12.3) |
| Change in Distress Symptoms at Pre-Maintenance | 6.2 (1.2 to 11.2) |
| Change in Distress Symptoms at Maintenance Cycle 6 | 5.9 (0.9 to 10.8) |
| Change in Distress Symptoms at Maintenance Cycle 12 | 5.7 (0.5 to 10.9) |
| Change in Distress Symptoms at Maintenance Cycle 18 | 3.8 (-1.7 to 9.3) |
| Change in Distress Symptoms at Maintenance Cycle 24 | 5.3 (-0.4 to 11.0) |
| Change in Side Effects of Treatment at Pre-Maintenance | -3.3 (-8.0 to 1.3) |
| Change in Side Effects of Treatment at Maintenance Cycle 6 | -0.7 (-5.3 to 3.9) |
| Change in Side Effects of Treatment at Maintenance Cycle 12 | -5.1 (-9.8 to -0.3) |
| Change in Side Effects of Treatment at Maintenance Cycle 18 | -2.4 (-7.4 to 2.5) |
| Change in Side Effects of Treatment at Maintenance Cycle 24 | -2.7 (-7.8 to 2.4) |
Collected over Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| D-PACE/Induction | 0/41 (0%) | 14/41 (34.1%) | 41/41 (100%) |
| Post D-PACE/Pre-Transplant | 0/41 (0%) | 2/41 (4.9%) | 8/41 (19.5%) |
| Transplant | 1/39 (2.6%) | 8/39 (20.5%) | 38/39 (97.4%) |
| Post-transplant/Consolidation | 0/38 (0%) | 4/38 (10.5%) | 8/38 (21.1%) |
| Maintenance Therapy, Year 1 | 1/37 (2.7%) | 11/37 (29.7%) | 27/37 (73%) |
| Maintenance Therapy, Year 2 | 0/31 (0%) | 9/31 (29%) | 22/31 (71%) |
| Long Term Follow-up | 0/24 (0%) | 1/24 (4.2%) | 3/24 (12.5%) |
| Event | D-PACE/Induction | Post D-PACE/Pre-Transplant | Transplant | Post-transplant/Consolidation | Maintenance Therapy, Year 1 | Maintenance Therapy, Year 2 | Long Term Follow-up |
|---|---|---|---|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 2/41 | 0/41 | 0/39 | 0/38 | 0/37 | 0/31 | 0/24 |
| Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/41 | 0/41 | 0/39 | 0/38 | 0/37 | 0/31 | 1/24 |
| Atrial fibrillationCardiac disorders | 0/41 | 0/41 | 0/39 | 0/38 | 0/37 | 1/31 | 0/24 |
| NauseaGastrointestinal disorders | 0/41 | 0/41 | 0/39 | 0/38 | 0/37 | 1/31 | 0/24 |
| VomitingGastrointestinal disorders | 0/41 | 0/41 | 0/39 | 0/38 | 0/37 | 1/31 | 0/24 |
| Lung infectionInfections and infestations | 0/41 | 0/41 | 0/39 | 0/38 | 0/37 | 1/31 | 0/24 |
| Lymphocyte count decreasedInvestigations | 0/41 | 0/41 | 0/39 | 0/38 | 0/37 | 1/31 | 0/24 |
| DehydrationMetabolism and nutrition disorders | 0/41 | 0/41 | 0/39 | 0/38 | 0/37 | 1/31 | 0/24 |
| Metabolism and nutrition disorders - Other, specifyMetabolism and nutrition disorders | 0/41 | 0/41 | 0/39 | 0/38 | 0/37 | 1/31 | 0/24 |
| SyncopeNervous system disorders | 0/41 | 0/41 | 0/39 | 0/38 | 0/37 | 1/31 | 0/24 |
| Event | D-PACE/Induction | Post D-PACE/Pre-Transplant | Transplant | Post-transplant/Consolidation | Maintenance Therapy, Year 1 | Maintenance Therapy, Year 2 | Long Term Follow-up |
|---|---|---|---|---|---|---|---|
| Lymphocyte count decreasedInvestigations | 41/41 | 8/41 | 36/39 | 8/38 | 27/37 | 22/31 | 0/24 |
| Platelet count decreasedInvestigations | 35/41 | 1/41 | 38/39 | 3/38 | 3/37 | 5/31 | 0/24 |
| White blood cell decreasedInvestigations | 39/41 | 0/41 | 38/39 | 3/38 | 4/37 | 4/31 | 0/24 |
| Neutrophil count decreasedInvestigations | 33/41 | 1/41 | 31/39 | 2/38 | 3/37 | 3/31 | 0/24 |
| AnemiaBlood and lymphatic system disorders | 15/41 | 2/41 | 30/39 | 1/38 | 3/37 | 2/31 | 0/24 |
| CD4 lymphocytes decreasedInvestigations | 2/41 | 7/41 | 1/39 | 6/38 | 23/37 | 14/31 | 0/24 |
| HypophosphatemiaMetabolism and nutrition disorders | 10/41 | 1/41 | 22/39 | 3/38 | 11/37 | 9/31 | 0/24 |
| HypocalcemiaMetabolism and nutrition disorders | 4/41 | 0/41 | 13/39 | 0/38 | 0/37 | 0/31 | 0/24 |
| Febrile neutropeniaBlood and lymphatic system disorders | 3/41 | 1/41 | 8/39 | 2/38 | 0/37 | 0/31 | 0/24 |
| DiarrheaGastrointestinal disorders | 0/41 | 0/41 | 7/39 | 2/38 | 2/37 | 2/31 | 0/24 |
| Age, Categorical(Participants) | Autologous Stem Cell Transplant |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 41 |
| Age, Continuous(years) | Autologous Stem Cell Transplant |
|---|---|
| Mean | 69 (65 to 75) |
| Sex: Female, Male(Participants) | Autologous Stem Cell Transplant |
|---|---|
| Female | 19 |
| Male | 22 |
| Ethnicity (NIH/OMB)(Participants) | Autologous Stem Cell Transplant |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 39 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Autologous Stem Cell Transplant |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 38 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Autologous Stem Cell Transplant |
|---|---|
| United States | 41 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2013 to primary completion in Sep 2020, 89 months.
Results were first posted in May 2022, 1 year 7 months after primary completion.
Of 31 phase 2 interventional studies under Immunoglobulin Light-chain Amyloidosis, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 89. This study's 89 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexamethasone · Cisplatin · Doxorubicin · Cyclophosphamide · Etoposide · Bortezomib · Thalidomide · Melphalan
Immunoglobulin Light-chain Amyloidosis →