Plasma Cell MyelomaPhase 2NCT03346135
Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma
A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Daratumumab and Laboratory Biomarker Analysis in people with Plasma Cell Myeloma and Secondary Amyloidosis, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
This phase II trial studies how well daratumumab after a stem cell transplant works in treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill cancer cells that are left after chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plasma Cell Myeloma, Secondary Amyloidosis
- What is being tested?
- Autologous Hematopoietic Stem Cell Transplantation, Daratumumab and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jan 2020to 17 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- Histologically confirmed diagnosis of multiple myeloma; (patients with multiple myeloma with secondary amyloidosis are eligible)
- Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-13 months of the first dose of initial therapy
- Eastern Cooperative Oncology Group (ECOG) =< 2
- Patients with planned standard of care ASCT using melphalan 200 mg/m^2; dose modifications in accordance with creatinine clearance levels are allowed per physician judgment
- Adequate organ function for high dose chemotherapy and autologous stem cell transplant (as per institution standard operating procedure [SOP])
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- Adequate cell dose > 2.5 x 10^6 CD34+ cells/kg
- Absolute neutrophil count (ANC) >= 1000/mm^3
- Platelet count >= 75,000/mm^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before study enrollment
- Total bilirubin =< 1.5 x the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) =< 3 x ULN
- Alanine aminotransferase (ALT) =< 3 x ULN
- Calculated creatinine clearance >= 30 mL/min
- Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of daratumumab for women)
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
Who cannot join
- Prior disease progression with daratumumab or other anti-CD38 antibody
- History of organ or previous autologous/allogeneic stem cell transplantation
- Any condition medical or psychosocial that in the opinion of the investigator would hinder compliance
- Female patients who are lactating or have a positive pregnancy test during the screening period
- Evidence of multiple myeloma (MM) disease progression any time prior to enrollment; progression from smoldering to active myeloma is not exclusionary
- History of plasma cell leukemia or central nervous system (CNS) involvement
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- Major surgery within 14 days prior to start of study treatment
- Infection requiring systemic antibiotic therapy within 14 days prior to the start of study treatment
- Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
- Vaccination with live attenuated vaccines within 4 weeks of first study agent administration
- Subject is currently using or has used immunosuppressive medication within 14 days prior to the first dose of study treatment; the following are exceptions:
- Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)
- Chronic systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
- Steroids as premedication for hypersensitivity reaction (e.g., infusion-related reactions, computed tomography [CT] scan premedication)
- Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis
- Subjects with uncontrolled, systematic infection should be excluded
- Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% predicted normal; Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 < 50%
- Subject has known moderate or severe persistent asthma within 2 years, or currently has uncontrolled asthma of any classification; (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
- Subject has active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., Crohn's disease], diverticulitis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis, etc) within the past 3 years prior to the start of treatment; the following are exceptions:
- Subjects with vitiligo or alopecia
- Subjects with hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement
- Psoriasis not requiring systemic treatment
- Subject has known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, or their excipients
- Subject has history of primary immunodeficiency
- Subject is seropositive for human immunodeficiency virus (HIV-1)
- Active hepatitis A
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]); subjects with resolved infection (I.e., subjects 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); EXCEPTION: Subjects with serologic finding suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
- 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)
- Subject has any one of the following:
- Clinically significant abnormal electrocardiogram (ECG) finding at screening
- Congestive heart failure (New York Heart Association class III or IV)
- Myocardial infarction within 12 months prior to starting study treatment
- Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
- Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for >= 5 years with the exception of the following malignancies:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system) or prostate cancer that is curative
- Any other condition that would, in the opinion of the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
About this study
Official title: A Multicenter, Open-Label, Single Arm, Phase II Study of Daratumumab as Consolidation/Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
This phase II trial studies how well daratumumab after a stem cell transplant works in treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill cancer cells that are left after chemotherapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the anti-myeloma activity of single-agent daratumumab post-autologous stem cell transplantation (ASCT) as assessed by progression-free survival at 1 year post ASCT.
SECONDARY OBJECTIVES:
- To characterize the extent of minimal residual disease (MRD) pre-/post-consolidation treatment segment and at one year during the maintenance treatment segment.
II. To characterize and evaluate toxicities, including type, frequency severity, attribution, and duration (e.g., infections, secondary primary malignancies, peripheral neuropathy).
III. To obtain estimates of overall response rate (stringent complete response [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]), response duration, depth of response, clinical benefit response, and overall survival.
EXPLORATORY OBJECTIVES:
- Quantify CD38+ cells from the peripheral blood mononuclear cells (PBMC) fraction, including T, natural killer (NK), and monocytic subsets using pre- and on-daratumumab treatment samples by flow cytometry.
II. Assess possible changes in CD38+ expression, as well as the co-receptor marker CD31, and possible correlation with response using pre- and on-daratumumab treatment samples by flow cytometry.
III. Assess cytokine levels in peripheral blood plasma. IV. Quantify CD38+ cells from the bone marrow CD-138 negative fractions and acellular fractions, including T, NK, and monocyte subsets using pre- and on-daratumumab treatment samples by flow cytometry.
- Assess possible changes in CD38+ expression, as well as the co-receptor marker CD31, and possible correlation with response using pre- and on-daratumumab treatment samples by flow cytometry.
VI. Assess cytokine levels in the bone marrow acellular fraction. VII. Investigate CD38 cellular localization in multiple myeloma cells and extracellular vesicles from blood plasma.
VIII. Assess messenger ribonucleic acid (mRNA) expression in the PBMC, the bone marrow CD130-negative fraction, the T cell fraction, and multiple myeloma cells.
IX. If differences in CD38 expression are found, investigate epigenetic changes in CD38 mRNA expression.
OUTLINE:
Patients undergo standard of care ASCT with a conditioning regimen of melphalan. Beginning 60-120 days after ASCT, patients receive daratumumab intravenously (IV) every week for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 18 months.
- Conditions
- Plasma Cell Myeloma, Secondary Amyloidosis
- Being tested
- Autologous Hematopoietic Stem Cell Transplantation, Daratumumab, Laboratory Biomarker Analysis, Melphalan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplantation, Stem Cell Transplantation, Autologous
Undergo standard of care ASCT with a conditioning regimen of melphalan
DaratumumabBiological
Also called Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
MelphalanDrug
Also called Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine mustard
Undergo standard of care ASCT with a conditioning regimen of melphalan
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ASCT, melphalan, daratumumab) | Experimental | Patients undergo standard of care ASCT with a conditioning regimen of melphalan. Beginning 60-120 days after ASCT, patients receive daratumumab IV every week for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Biological: Daratumumab; Other: Laboratory Biomarker Analysis; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Will be estimated using the product-limit method of Kaplan-Meier.
Measured: From date of first dose of study drug to first documented date of disease relapse, progression, or death (from any cause), whichever occurs first, assessed for up to 18 months after last dose of study drug
Secondary outcomes (7)
Minimal residual disease (MRD) defined as if a positive result is obtained using the Adaptive MRD testing
Measured: Up to 30 days after last dose of study drug
Incidence of adverse events graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0
Measured: Up to 30 days after last dose of study drug
Overall response rate (stringent complete response [sCR]/complete response [CR], very good partial response [VGPR]) based on the International Myeloma Working Group (IMWG) Uniform Response Criteria
Will be calculated as the percent of evaluable patients that have confirmed sCR/CR/VGPR (overall) or sCR/CR/VGPR/partial response (PR)/minimal response (MR) or stable disease (SD) (clinical benefit). Exact 95% confidence intervals will be calculated for these estimates. Will also be evaluated based on the number and type of prior therapy(ies).
Measured: At 1 year
Response duration
Measured: From the date of first documented response (sCR/CR/VGPR) to documented disease relapse, progression, or death, whichever occurs first, assessed up to 18 months after last dose of study drug
Depth of response
Will be calculated as the percent of evaluable patients that have confirmed sCR/CR/VGPR (overall) or sCR/CR/VGPR/PR/MR or SD (clinical benefit). Exact 95% confidence intervals will be calculated for these estimates.
Measured: Up to 18 months after last dose of study drug
Clinical benefit response based on the IMWG criteria
Will be calculated as the number of responders plus those with a PR, MR, or SD, divided by the number of evaluable patients. Exact 95% confidence intervals will be calculated for these estimates.
Measured: Up to 18 months after last dose of study drug
Overall survival
Will be estimated using the product-limit method of Kaplan-Meier.
Measured: From date of first dose of study drug to date of death from any cause, assessed for up to 18 months after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start6 Jan 2020
- Primary completion17 May 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amrita Y Krishnan, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346135
- Sponsor's protocol ID
- 18560
- Other IDs
- NCI-2017-02087, 18560
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2017
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Single Arm, Phase II Study of Daratumumab as Consolidation/Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03346135
- Acronym / sponsor ID
- 18560
- Conditions
- Plasma Cell Myeloma, Secondary Amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well daratumumab after a stem cell transplant works in treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill cancer cells that are left after chemotherapy.
Detailed description
PRIMARY OBJECTIVE:
- To determine the anti-myeloma activity of single-agent daratumumab post-autologous stem cell transplantation (ASCT) as assessed by progression-free survival at 1 year post ASCT.
SECONDARY OBJECTIVES:
- To characterize the extent of minimal residual disease (MRD) pre-/post-consolidation treatment segment and at one year during the maintenance treatment segment.
II. To characterize and evaluate toxicities, including type, frequency severity, attribution, and duration (e.g., infections, secondary primary malignancies, peripheral neuropathy).
III. To obtain estimates of overall response rate (stringent complete response [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]), response duration, depth of response, clinical benefit response, and overall survival.
EXPLORATORY OBJECTIVES:
- Quantify CD38+ cells from the peripheral blood mononuclear cells (PBMC) fraction, including T, natural killer (NK), and monocytic subsets using pre- and on-daratumumab treatment samples by flow cytometry.
II. Assess possible changes in CD38+ expression, as well as the co-receptor marker CD31, and possible correlation with response using pre- and on-daratumumab treatment samples by flow cytometry.
III. Assess cytokine levels in peripheral blood plasma. IV. Quantify CD38+ cells from the bone marrow CD-138 negative fractions and acellular fractions, including T, NK, and monocyte subsets using pre- and on-daratumumab treatment samples by flow cytometry.
- Assess possible changes in CD38+ expression, as well as the co-receptor marker CD31, and possible correlation with response using pre- and on-daratumumab treatment samples by flow cytometry.
VI. Assess cytokine levels in the bone marrow acellular fraction. VII. Investigate CD38 cellular localization in multiple myeloma cells and extracellular vesicles from blood plasma.
VIII. Assess messenger ribonucleic acid (mRNA) expression in the PBMC, the bone marrow CD130-negative fraction, the T cell fraction, and multiple myeloma cells.
IX. If differences in CD38 expression are found, investigate epigenetic changes in CD38 mRNA expression.
OUTLINE:
Patients undergo standard of care ASCT with a conditioning regimen of melphalan. Beginning 60-120 days after ASCT, patients receive daratumumab intravenously (IV) every week for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ASCT, melphalan, daratumumab) | Experimental | Procedure: Autologous Hematopoietic Stem Cell Transplantation, Biological: Daratumumab, Other: Laboratory Biomarker Analysis, Drug: MelphalanPatients undergo standard of care ASCT with a conditioning regimen of melphalan. Beginning 60-120 days after ASCT, patients receive daratumumab IV every week for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- Histologically confirmed diagnosis of multiple myeloma; (patients with multiple myeloma with secondary amyloidosis are eligible)
- Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-13 months of the first dose of initial therapy
- Eastern Cooperative Oncology Group (ECOG) =< 2
- Patients with planned standard of care ASCT using melphalan 200 mg/m^2; dose modifications in accordance with creatinine clearance levels are allowed per physician judgment
Key exclusion criteria (41 listed)
- Prior disease progression with daratumumab or other anti-CD38 antibody
- History of organ or previous autologous/allogeneic stem cell transplantation
- Any condition medical or psychosocial that in the opinion of the investigator would hinder compliance
- Female patients who are lactating or have a positive pregnancy test during the screening period
- Evidence of multiple myeloma (MM) disease progression any time prior to enrollment; progression from smoldering to active myeloma is not exclusionary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Hematopoietic Stem Cell TransplantationAlso: Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplantation, Stem Cell Transplantation, AutologousUndergo standard of care ASCT with a conditioning regimen of melphalan | Procedure or surgery | Treatment (ASCT, melphalan, daratumumab) |
| DaratumumabAlso: Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414Given IV | Biological | Treatment (ASCT, melphalan, daratumumab) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (ASCT, melphalan, daratumumab) |
| MelphalanAlso: Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine mustardUndergo standard of care ASCT with a conditioning regimen of melphalan | Drug | Treatment (ASCT, melphalan, daratumumab) |
Primary outcome
Progression-free survival
Time frame: From date of first dose of study drug to first documented date of disease relapse, progression, or death (from any cause), whichever occurs first, assessed for up to 18 months after last dose of study drug
Will be estimated using the product-limit method of Kaplan-Meier.
7 secondary outcomes
Minimal residual disease (MRD) defined as if a positive result is obtained using the Adaptive MRD testing
Time frame: Up to 30 days after last dose of study drug
Incidence of adverse events graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0
Time frame: Up to 30 days after last dose of study drug
Overall response rate (stringent complete response [sCR]/complete response [CR], very good partial response [VGPR]) based on the International Myeloma Working Group (IMWG) Uniform Response Criteria
Time frame: At 1 year
Response duration
Time frame: From the date of first documented response (sCR/CR/VGPR) to documented disease relapse, progression, or death, whichever occurs first, assessed up to 18 months after last dose of study drug
Depth of response
Time frame: Up to 18 months after last dose of study drug
Clinical benefit response based on the IMWG criteria
Time frame: Up to 18 months after last dose of study drug
Overall survival
Time frame: From date of first dose of study drug to date of death from any cause, assessed for up to 18 months after last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amrita Y Krishnan principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Daratumumab and Laboratory Biomarker Analysis in people with Plasma Cell Myeloma and Secondary Amyloidosis, run by City of Hope Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of first dose of study drug to first documented date of disease relapse, progression, or death (from any cause), whichever occurs first, assessed for up to 18 months after last dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.