Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Neoplasm, Residual

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

sequential blood draw taken to monitor residual disease

blood draw

Pirkko-Liisa Kellokumpu-Lehtinen, professor

Circulating tumour DNA (ctDNA) is a promising tool when monitoring the residual disease in colorectal cancer (CRC). Current staging procedures are insufficient to identify the patient cohort at high risk, who might benefit from additional adjuvant therapy.

We will show that the assessment of ctDNA is a non-invasive approach and easily taken at different time points via simple blood draw to monitor residual disease from the colorectal cancer patients after primary surgery. Minimal residual disease could be used in the future for individualized treatment decisions after primary surgery.

Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases

residual disease measured by sequential blood draws

Tampere University Hospital

professor

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Vaccines

Capecitabine

Immunomodulating Agents

Participants diagnosed with triple negative breast cancer (TNBC) will be treated with successively higher doses of α-lactalbumin and zymosan in a traditional 3 + 3 phase I trial design. Treatment will involve a course of 3 vaccinations given every 2 weeks. Participants will be enrolled sequentially into 1 of 5 different dose levels each comprised of cohorts of 1-6 participants until the MTD has been identified (intra-patient dose escalation not permitted), after which the MTD will be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until the lowest DL associated with immune response has been expanded.

Dose Level (DL) 1: 10 microgram (mcg) a-lactalbumin + 10 mcg Zymosan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1c: 50 mcg a-lactalbumin + 50 mcg Zymosan DL1d: 50 mcg a-lactalbumin + 30 mcg Zymosan (DL1d will only be utilized if 1c is too toxic)

Participants with a genetic risk for developing TNBC who plan to undergo prophylactic mastectomy will be treated with α-lactalbumin and zymosan at doses based on the TNBC cohort. Treatment will involve a course of 3 vaccinations given every 2 weeks. Participants enrolled in the prevention cohort we will be enrolled at the dose level being used in the TNBC cohort if no DLTs above Grade 1 have been observed. If the TNBC cohort proceeds to the next dose level before another prevention cohort patient is enrolled, the next prevention patient will be enrolled on the next dose level along with the TNBC cohort.

Dose Level (DL) 1: 10 microgram (mcg) a-lactalbumin + 10 mcg Zymosan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1c: 50 mcg a-lactalbumin + 50 mcg Zymosan DL1d: 50 mcg a-lactalbumin + 30 mcg Zymosan (DL1d will only be utilized if 1c is deemed too toxic)

Participants undergoing chemo-immunotherapy for operable triple-negative breast cancer will be treated with α-lactalbumin concurrently with standard of care adjuvant pembrolizumab after having completed all pre- and postoperative chemotherapy and radiation therapy, with the exception of Xeloda/capecitabine at provider discretion. Treatment will involve 3 vaccinations given every 2 weeks. Participants enrolled in the Pembrolizumab cohort will be enrolled at the proper Optimal Immunologic Dose as defined by the TNBC and preventative cohorts and based on information available at the time of study entry.

Dose Level (DL) 1: 10 microgram (mcg) a-lactalbumin + 10 mcg Zymosan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1c: 50 mcg a-lactalbumin + 50 mcg Zymosan DL1d: 50 mcg a-lactalbumin + 30 mcg Zymosan (DL1d will only be utilized if 1c is deemed too toxic)

α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy).

DL1: 10 mcg

DL2: 100 mcg

DL3: 500 mcg

D1b: 50 mcg

D1c: 50 mcg

D1d: 50 mcg (D1d will only be utilized if D1c is deemed too toxic)

α-lactalbumin vaccine

Adjuvant used in vaccine preparation

DL1: 10 mcg

DL2: 100 mcg

DL3: 10 mcg

D1b: 10 mcg

D1c: 50 mcg

D1d: 30 mcg (D1d will only be utilized if D1c is deemed too toxic)

Zymosan

George T Budd, MD

The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer, participants who are of cancer-free but may be at risk for triple-negative breast cancer, and for participants who are receiving adjuvant pembrolizumab following initial triple negative breast cancer treatment.

This is an open-label, phase I dose-escalation trial that will be performed on three successive cohorts. The first cohort is comprised of participants with high-risk triple-negative breast cancer. The second is made up of participants scheduled to undergo bilateral prophylactic mastectomy due to their genetic risk of triple-negative breast cancer. The third cohort is comprised of participants who have had treatment for their triple-negative breast cancer treatment, receiving adjuvant pembrolizumab. These cohorts will be treated with successively higher doses of α-lactalbumin and zymosan.

This aLA breast cancer vaccine is an investigational (experimental) drug that the study team believes will work by stimulating the immune system to fight the participant's cancer, in a way similar to the way the immune system fights off an infection after a vaccination for that infection. α-lactalbumin Vaccine is experimental because it is not approved by the Food and Drug Administration (FDA).

A traditional "3+3" Phase I trial design will be employed for the cohorts to determined the Maximum Tolerated Dose (MTD). After identification of the MTD, if at least 1 participant has an immunologic response (correlative measurement), successively lower dose levels will be expanded to a total of 6 participants and immunologic response assessed. Enrollment will stop if a dose level is reached for which no responses are observed. Dose-Limiting toxicities (DLTs) in 2 or more of 6 participants, the next lower dose will be considered the new MTD.

Objectives are to determine MTD, DLT incidence, and Lowest Immunologic Dose (LID) for each cohort.

Toxicity will be assessed every 2 weeks until day 56 and at day 84 or at off-study. Participants will be offered participation in long-term follow-up involving contact or in-person follow-up for late toxicity and survival every 3 months for 2 years, every 6 months for an additional 3 years, and then annually for 10 years.

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence

Yes, the data will be shared with the FDA, the Department of Defense (DOD), and Anixa Biosciences who has negotiated rights to the drug, and any pharmaceutical partner who may wish to negotiate rights to the drug. All below may be shared, with patient data anonymized

MTD of an α-lactalbumin vaccine in participants with operable triple-negative breast cancer

MTD of an α-lactalbumin vaccine in participants at risk for TNBC who are scheduled for prophylactic double mastectomy.

MTD of an α-lactalbumin vaccine in participants who are receiving adjuvant pembrolizumab following initial TNBC treatment.

LID of α-lactalbumin vaccine in participants with operable triple-negative breast cancer, based on ELISPOT assays to assess the ability to induce a pro-inflammatory T cell response consistent with tumor protection. This assessment will be determined using the ELISPOT assay to determine peripheral blood frequencies of T cells that produce interferon-gamma (IFNγ; type-1) and IL-17 (type-17) in response to recombinant human α-lactalbumin

LID of α-lactalbumin vaccine in participants at risk for TNBC who are scheduled for prophylactic double mastectomy, based on ELISPOT assays to assess the ability to induce a pro-inflammatory T cell response consistent with tumor protection. This assessment will be determined using the ELISPOT assay to determine peripheral blood frequencies of T cells that produce interferon-gamma (IFNγ; type-1) and IL-17 (type-17) in response to recombinant human α-lactalbumin

LID of α-lactalbumin vaccine in participants who are receiving adjuvant pembrolizumab following initial TNBC treatment, based on ELISPOT assays to assess the ability to induce a pro-inflammatory T cell response consistent with tumor protection. This assessment will be determined using the ELISPOT assay to determine peripheral blood frequencies of T cells that produce interferon-gamma (IFNγ; type-1) and IL-17 (type-17) in response to recombinant human α-lactalbumin

United States Department of Defense

Anixa Biosciences, Inc.

George T. Budd

Principal Investigator

Pathologic Complete Response

Disease Progression

Disease Attributes

Trastuzumab

Antineoplastic Agents, Immunological

Eribulin 1.4 mg/m\^2 intravenously (IV)

Trastuzumab 6mg/kg intravenously (IV)

1.4 mg/m\^2 IV Days 1 and 8, every 21 days for six cycles

Eribulin

Denise A Yardley, M.D.

The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive breast cancers.

This is a non-randomized, open-label trial to evaluate 6 cycles of eribulin in female patients with invasive breast cancer who do not achieve pathologic complete response (pCR) after treatment with a standard neoadjuvant chemotherapy and surgery regimen. Patients will be randomized into three cohorts according to tumor-type: triple-negative (Cohort A), hormone-receptor-positive/HER2-negative (Cohort B), and HER2-positive (Cohort C) tumors. Patients will receive eribulin for 6 cycles (1 cycle = 21 days). Patients with HER2-positive tumors will also receive trastuzumab. Patients in all cohorts will be allowed to receive locoregional radiotherapy and/or adjuvant hormonal therapy per institutional guidelines.

Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

Phase II Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Examines the feasibility of administering 6 cycles (21 days per cycle) of eribulin without toxicity or disease worsening following standard neoadjuvant chemotherapy and surgery.

A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.

Eisai Inc.

SCRI Development Innovations, LLC

All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Patients with Triple-Negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.

Cohort A: Triple-negative Breast Cancer

Patients with ER positive and/or PR positive, HER-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.

Cohort B: ER/PR Positive/HER2-negative Breast Cancer

Patients with HER2-postive breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route. Patients will also concurrently receive trastuzumab 6 mg/kg IV on Day 1 every 21 days.

Cohort C: HER2 Positive Breast Cancer

Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.

Cohort A: Triple-negative Breast Cancer Patients

Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.

Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients

Cohort C: HER2-positive Breast Cancer Patients

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

All patients who receive at least one dose of treatment.

Senior Director, Regulatory Science

Patients who receive at least one dose of treatment

Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy

All patients who received at least one dose of treatment

Number of Patients Who Completed Eribulin Therapy as an Assessment of Treatment Feasibility

The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety

Enrolled

Treated

Antimetabolites

1000 mg/m2 administered on Days 1 to 14 of 21-day cycles

1000 mg/m2 administered on Days 1 to 14 of 21-day treatment cycles, for 8 cycles.

Cindy Garcia

Melinda Telli, MD

Melinda Telli

The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from treatment with capecitabine. Participants will be monitored for changes in ctDNA in the blood over time received during capecitabine treatment. Results of ctDNA analysis will be correlated to genetic characteristics of individual tumors. This may inform future clinical trials in which patients could receive a different treatment than capecitabine to reduce their risk of breast cancer relapse.

The Primary Objective is to characterize the circulating tumor DNA (ctDNA) profile of triple-negative breast cancer (TNBC) in participants with residual disease after standard neoadjuvant chemotherapy (NAC) receiving standard-of-care adjuvant capecitabine.

The Secondary Objectives are to correlate ctDNA levels with genomic features and survival.

Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer

Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy

In participants with triple-negative breast cancer (TNBC) who have received standard neoadjuvant chemotherapy (NAC), levels of circulating tumor DNA (ctDNA) will be assessed at baseline and after 6 months of standard adjuvant capecitabine treatment. The outcome will be reported as the number of participants who are:

* ctDNA+ (ctDNA-positive) at baseline and at 6 months.
* ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months.
* ctDNA- at baseline and at 6 months.
* ctDNA- at baseline but ctDNA+ at 6 months.

The outcome is a number without dispersion.

Genomic status of certain mutations in the tumor will be assessed by next-generation sequencing in participants who are:

* ctDNA+ (ctDNA-positive) at baseline and at 6 months.
* ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months.
* ctDNA- at baseline and at 6 months.
* ctDNA- at baseline but ctDNA+ at 6 months.

The genes of interest are:

PIK3CA AKT AKT1 PTEN BRCA1 BRCA2 PALB2 CHEK2 ATM NBN BRIP1 BARD1 MRE11 ATR RAD50 RAD51C RAD51D FANCA FANCC FANCD2 FANCE FANCF FANCG FANCL.

The outcome will be reported as the number of participants with a positive mutation status in the gene of interest. The outcome is a number without dispersion.

Overall survival (OS) will be assessed as participants remaining alive 5 years from the first treatment initiation. The outcome is reported as the number of participants alive (without dispersion).

Relapse-free survival is defined as the time from treatment initiation to first invasive relapse or death, through 5 years. The outcome is reported as the number of participants with relapse-free survival (without dispersion) at 5 years.

Stanford University

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

* Niraparib will be administered orally on a daily basis
* Radiation Therapy will be administered concurrently with Niraparib

Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring.

Radiation Therapy

Alice Ho, MD

Jennifer Bellon, MD

This research study involves Niraparib as a possible treatment for triple negative breast cancer.

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved niraparib for this specific disease but it has been approved for other uses.

Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring.

This trial is studying people who have triple negative breast cancer because this cancer type is shown to have DNA repair mechanisms that may benefit from combined PARP inhibitor and radiation, and may help prevent recurrence of cancers in the chest wall and lymph nodes of the affected side.

A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients

A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients (UNITY)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The proportion of subjects tolerating each maximum dose level. The trial will be monitored using a 3+3 dose escalation method.

The incidence of recurrence of breast cancer in the ipsilateral chest wall or regional lymph nodes will be captured

The incidence of recurrence of breast cancer in regions outside of the ipsilateral chest wall or regional lymph nodes will be captured

Adverse events will be assessed using common terminology criteria for adverse events (CTCAE) v5.

Breast cosmesis will be assessed using the Radiation Therapy Oncology Group (ROTG) cosmesis assessment criteria. Brest cosmesis will be reported as the number of participants reporting excellent/good or fair/poor cosmetic results.

Tesaro, Inc.

Massachusetts General Hospital

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anticoagulants

Anti-Infective Agents

Other Dietary Supplements

Amino Acids

Dexamethasone

Lenalidomide

Dexamethasone acetate

Citric Acid

Sodium Citrate

Ixazomib

Proteasome Inhibitors

Glycine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

Neurotransmitter Agents

Citrate

Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).

Patients receive lenalidomide PO as in Arm I.

Ixazomib Citrate

Andrzej Jakubowiak

This randomized phase II trial studies how well lenalidomide alone compared to lenalidomide, ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that remains (residual) after donor stem cell transplant. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells and may also prevent the growth of new blood vessels that are needed for cancer growth. Ixazomib citrate may stop the growth of cancer cells by interfering with proteins necessary for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide is more effective with or without ixazomib citrate and dexamethasone in treating residual multiple myeloma.

PRIMARY OBJECTIVES:

I. To determine the rate of minimal residual disease (MRD)-negative disease by multiparameter-flow cytometry at 12 months after randomization.

SECONDARY OBJECTIVES:

I. Evidence of response as demonstrated by the improvement of the depth of response by at least one category according to International Myeloma Working Group (IMWG) response criteria.

II. Progression free survival (PFS). III. Overall survival (OS). IV. Duration of MRD-negative disease. V. Safety and tolerability of experimental arm (ixazomib citrate, lenalidomide, and low dose dexamethasone \[IRd\]) vs. control arm (lenalidomide \[Rd\]).

TERTIARY OBJECTIVES:

I. Determination of markers of response based on pre-treatment characteristics using methods described in correlative research.

II. Evaluation of MRD by gene sequencing method using the Sequenta platform (LymphoSIGHT®) in parallel with multi-parameter flow cytometry (MFC).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, lenalidomide PO once daily (QD) on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).

ARM II: Patients receive lenalidomide PO as in Arm I.

In both arms, treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

After the completion of treatment, patients are followed up at 30 days and then every 3 months for 2 years.

Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant

Phase II Randomized Trial of Continuation of Post-Transplant Maintenance With Single-Agent Lenalidomide vs. Consolidation/Maintenance With Ixazomib-Lenalidomide-Dexamethasone in Patients With Residual Myeloma

Correlative biomarkers will be assessed for association with response in the experimental arm using nonparametric tests given the relatively small number of responders anticipated (20%). A Wilcoxon rank-sum test will be used to compare baseline (pre-treatment) biomarker levels in the responders vs. non-responders.

The comparison will be made using a one sided test at the 10% significance level. This comparison will be performed using a Cochran Mantel-Haenszel (CMH) test stratified by very good partial response (VGPR) status and risk factors vs. no risk factors.

The rate of overall response will be reported along with its exact 95% binomial confidence interval.

Duration of response will be assessed conditionally upon achieving at least a partial response.

Time to event will be estimated using the product-limit method of Kaplan and Meier.

Time to event will be estimated using the product-limit method of Kaplan and Meier. MRD status will be correlated with PFS.

Safety variables will be tabulated and presented for all patients in the study. Exposure to study drug and reasons for discontinuation of study treatment will be tabulated. Group comparisons will be performed using chi-square or Fisher's exact test.

National Cancer Institute (NCI)

Multiple Myeloma Research Foundation

University of Chicago

blood samples and bone marrow aspirates will be collected in patients at different time point

Serial analysis will be performed at different time point in order to evaluate the presence or absence of residual disease after different treatment steps (before treatment, after induction, after intensification, after consolidation)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases	NCT03189576	Colorectal Canc... Residual Diseas...	blood draw	-	Tampere University Hospital
Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer	NCT04674306	Pathologic Stag... TNBC - Triple-N... Residual Diseas...	α-lactalbumin v... Zymosan	18 Years -	Case Comprehensive Cancer Center
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy	NCT01401959	Metastatic Brea...	Eribulin Trastuzumab	18 Years -	SCRI Development Innovations, LLC
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer	NCT04768426	Triple Negative... Breast Cancer	Capecitabine	18 Years -	Stanford University
A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients	NCT03945721	Triple Negative... Residual Diseas...	Niraparib Radiation Thera...	18 Years -	Massachusetts General Hospital
Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant	NCT02389517	Plasma Cell Mye... Residual Diseas...	Ixazomib Citrat... Lenalidomide Dexamethasone	18 Years -	University of Chicago
Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer	NCT04674306	Pathologic Stag... TNBC - Triple-N... Residual Diseas...	α-lactalbumin v... Zymosan	18 Years -	Case Comprehensive Cancer Center
Multiple Myeloma Minimal Residual Disease	NCT02627261	Multiple Myelom...	blood samples a...	18 Years -	Hospices Civils de Lyon
Validation of a Score That Predicts Residual Disease in Incidental Gallbladder Cancer	NCT04321577	Gallbladder Neo...	Radical surgery	-	Hospital Universitari de Bellvitge
Phase II Trial GA101 Inbrutinib B CLL	NCT02666898	Leukemia, Lymph...	GA101 Ibrutinib Cyclophosphamid... Fludarabine	18 Years -	French Innovative Leukemia Organisation
A Study of Tetrathiomolybdate (TM) Plus Capecitabine	NCT06134375	Triple Negative... Residual Diseas...	Tetrathiomolybd... Capecitabine Pembrolizumab	18 Years - 70 Years	Dartmouth-Hitchcock Medical Center
Multiple Myeloma Minimal Residual Disease	NCT02627261	Multiple Myelom...	blood samples a...	18 Years -	Hospices Civils de Lyon

Spots Global Cancer Trial Database for residual disease