Trial · NCT03910439
Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma
NCT03910439, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2021-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma. Trials, record NCT03910439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03910439
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma
- NCT number
- NCT03910439
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Myeloma, Multiple, Myeloma-Multiple
- Interventions
- Avelumab, External beam radiotherapy
- First posted
- 2019-04-10
- Last updated
- 2021-05-12
- Results first posted
- 2021-04-20
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | up to end of study, an average of 11 months | ORR is defined as participants who experience a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) per International Myeloma Working Group Criteria (IMWG) 2016 criteria. Complete Response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Stringent Complete Response is defined as complete response as noted previously plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immune-histochemistry. Partial Response is ≥50% reduction of serum M-protein plus reduction in 24 hour(h) urinary M-protein by ≥90% or to \<200 mg per 24 h. Very Good Partial Response is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 h. |
| Secondary | Fraction of Participants Who Experience a Complete Response (CR) or Stringent Complete Response (sCR) Using the Study Treatment | up to end of study for individual patient, an average of 11 months | Response was assessed by the International Myeloma Working Group (IMWG) response criteria, 2016. Complete Response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Stringent Complete Response is defined as complete response as noted previously plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immune-histochemistry. |
| Secondary | Fraction of Participants Who Experience a Minimal Residual Disease Negative (MRDneg)Complete Response (CR) Using the Study Treatment | up to up to end of study for individual patient, an average of 11 months | Response was assessed by the International Myeloma Working Group Criteria (IMWG) 2016 criteria. Sustained MRDnegCR is defined as negativity in the marrow (next-generation flow (NGF) or next-generation sequencing (NGS), or both) and by imaging confirmed minimum of 1 year apart. |
| Secondary | Percent Change in Aberrant Circulating Plasma Cells in the Peripheral Blood (PB) and Bone Marrow (BM) From Baseline | Baseline and up to end of study for individual patient, an average of 11 months | Blood samples and bone marrow samples were taken from participants and processed by flow cytometry. |
| Secondary | Percent Reduction in Size of On-irradiated Extramedullary Lesions | end of study | Radiographic reduction in size of non-irradiated extramedullary lesions. |
| Secondary | Fluorodeoxyglucose (FDG) Avidity Positron-Emission Tomography/Computed Tomography (PET/CT) of Non-irradiated Extramedullary Lesions (Abscopal Effect) Compared to Baseline | End of study | FDG avidity of extramedullary lesions. |
| Secondary | Progression-free Survival (PFS) | End of study, an average of 11 months | PFS was defined as those who progress or die without progression as failures, and censoring those who do not. Progressive disease was assessed by the 2016 International Myeloma Working Group (IMWG) response criteria and is an increase of 25% from lowest confirmed response value in one or more of the following criteria: Serum M-protein (absolute increase must be ≥0·5 g/dL); Serum M-protein increase ≥1 g/dL, if the lowest M component was ≥5 g/dL; Urine M-protein (absolute increase must be ≥200 mg/24 h); In patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be \>10 mg/dL). |
| Secondary | Percentage of Participants With Overall Survival (OS) | Enrollment through end of study, an average of 11 months | Participants who are alive following enrollment and study treatment. |
| Secondary | Number of Participants With Grade ≥1 Non-serious Adverse Events | Date treatment consent signed to date off study, approximately 14 months and 4 days. | Grade ≥1 non-serious adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. Grade 1 is mild, Grade 2 is moderate, and Grade 3 is severe or medically significant. |
| Secondary | Number of Participants Overall Best Response | 4 weeks | Response was assessed by the International Myeloma Working Group (IMWG) response criteria, 2016. Minimal Response is ≥25% but ≤49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%; in addition, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required. Stable Disease is not meeting criteria for complete response, very good partial response, partial response, minimal response, or progressive disease. And Progressive Disease is appearance of a new lesion(s), ≥50% increase from nadir in sum of the products of diameters (SPD) of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1 cm in short axis; ≥50% increase in circulating plasma cells (minimum of 200 cells per microliter (μL) if this is the only measure of disease. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | up to end of study, an average of 11 months | Proportion of participants | NUMBER | |
| SECONDARY | Fraction of Participants Who Experience a Complete Response (CR) or Stringent Complete Response (sCR) Using the Study Treatment | up to end of study for individual patient, an average of 11 months | Proportion of participants | NUMBER | |
| SECONDARY | Fraction of Participants Who Experience a Minimal Residual Disease Negative (MRDneg)Complete Response (CR) Using the Study Treatment | up to up to end of study for individual patient, an average of 11 months | Proportion of participants | NUMBER | |
| SECONDARY | Percent Change in Aberrant Circulating Plasma Cells in the Peripheral Blood (PB) and Bone Marrow (BM) From Baseline | Baseline and up to end of study for individual patient, an average of 11 months | Percent change | MEAN | |
| SECONDARY | Percent Reduction in Size of On-irradiated Extramedullary Lesions | end of study | This outcome measure was not evaluated due to study closure. | ||
| SECONDARY | Fluorodeoxyglucose (FDG) Avidity Positron-Emission Tomography/Computed Tomography (PET/CT) of Non-irradiated Extramedullary Lesions (Abscopal Effect) Compared to Baseline | End of study | This outcome measure was not evaluated due to study closure. | ||
| SECONDARY | Progression-free Survival (PFS) | End of study, an average of 11 months | Months | MEDIAN | |
| SECONDARY | Percentage of Participants With Overall Survival (OS) | Enrollment through end of study, an average of 11 months | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Grade ≥1 Non-serious Adverse Events | Date treatment consent signed to date off study, approximately 14 months and 4 days. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Overall Best Response | 4 weeks | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | Complete Response | 0 | 95% Confidence Interval 0 to 0 | Proportion of participants |
| Overall Response Rate (ORR) | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | Stringent Complete Response | 0 | 95% Confidence Interval 0 to 0 | Proportion of participants |
| Overall Response Rate (ORR) | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | Partial Response | 0 | 95% Confidence Interval 0 to 0 | Proportion of participants |
| Overall Response Rate (ORR) | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | Very Good Partial Response | 0 | 95% Confidence Interval 0 to 0 | Proportion of participants |
| Fraction of Participants Who Experience a Complete Response (CR) or Stringent Complete Response (sCR) Using the Study Treatment | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 0 | 95% Confidence Interval 0 to 0 | Proportion of participants | |
| Fraction of Participants Who Experience a Minimal Residual Disease Negative (MRDneg)Complete Response (CR) Using the Study Treatment | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 0 | 95% Confidence Interval 0 to 0 | Proportion of participants | |
| Percent Change in Aberrant Circulating Plasma Cells in the Peripheral Blood (PB) and Bone Marrow (BM) From Baseline | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | Peripheral blood at baseline | 0 | Full Range 0 to 0 | Percent change |
| Percent Change in Aberrant Circulating Plasma Cells in the Peripheral Blood (PB) and Bone Marrow (BM) From Baseline | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | Bone marrow at baseline | 0 | Full Range 0 to 0 | Percent change |
| Percent Change in Aberrant Circulating Plasma Cells in the Peripheral Blood (PB) and Bone Marrow (BM) From Baseline | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | Peripheral blood at end of study | 18 | Full Range -1 to 1000 | Percent change |
| Percent Change in Aberrant Circulating Plasma Cells in the Peripheral Blood (PB) and Bone Marrow (BM) From Baseline | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | Bone marrow at end of study | 55 | Full Range -0.01 to 1250 | Percent change |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 4 | |
| Overall Study | COMPLETED | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 4 | |
| Overall Study | NOT COMPLETED | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 3 |
| other | Alkaline phosphatase increased | Investigations | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 1 |
| other | Aspartate aminotransferase increased | Investigations | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 2 |
| other | Chest pain - cardiac | Musculoskeletal and connective tissue disorders | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 1 |
| other | Eye disorders - Other, posterior vitreous detachment | Eye disorders | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 1 |
| other | Nausea | Gastrointestinal disorders | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 1 |
| other | Pain | General disorders | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 2 |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 1 |
| other | Skin infection | Infections and infestations | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 1 | 4 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 0 | 4 |
| Total, other adverse events | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 4 | 4 |
| Total, serious adverse events | 1/Avelumab 800 mg Intravenous (IV) Every Two Weeks in Combination With Radiation Therapy | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03910439
GET https://conductscience.org/api/trials/v1/NCT03910439/results?page=2