CLINICAL TRIAL

KRdD followed by auto-HCT for Multiple Myeloma

Newly Diagnosed
Relapsed
Waitlist Available · 18+ · All Sexes · Madison, WI

This study is evaluating whether a new treatment for multiple myeloma may help patients live longer.

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About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma · Neoplasms, Plasma Cell

Treatment Groups

This trial involves 2 different treatments. KRdD Followed By Auto-HCT is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
KRdD only
DRUG
Experimental Group 2
KRdD followed by auto-HCT
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Multiple Myeloma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Serum monoclonal (M) protein ≥1.0 g/dl
≥ 200 mg of M protein/24h in the urine
Serum-free light chain ≥10 mg/dL and abnormal kappa to lambda ratio.
Life expectancy ≥12 months.
Adequate hepatic function, with serum ALT ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 μmol/L) within 21 days prior to initiation of therapy.
Age >18 years with no upper age limit
Diagnosis of newly diagnosed multiple myeloma with indication for initiation of therapy.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m2) and/or cyclophosphamide up to 1000 mg/m2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than 4 weeks prior to enrollment. If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available.
Creatinine clearance (CrCl) ≥ 40 mL/minute within 21 days prior to start of therapy either measured or calculated using a standard formula (eg. Cockcroft and Gault).
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether KRdD followed by auto-HCT will improve 1 primary outcome and 7 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Baseline until MRD(-) status estimated at 6 months or until disease progression.

Percentage of patients with MRD(-) status at the completion of induction therapy
BASELINE UNTIL MRD(-) STATUS ESTIMATED AT 6 MONTHS OR UNTIL DISEASE PROGRESSION
The primary endpoint of MRD(-) rate will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences.
BASELINE UNTIL MRD(-) STATUS ESTIMATED AT 6 MONTHS OR UNTIL DISEASE PROGRESSION
Percentage of patients with auto-HCT that convert from positive to negative MRD
FROM BASELINE UP TO AN ESTIMATED 9 MONTHS
The primary endpoint of MRD(-) rate will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences.
FROM BASELINE UP TO AN ESTIMATED 9 MONTHS
Serious adverse events (SAEs) from the KRdD treatment
BASELINE UNTIL THE PROGRESSION OF DISEASE OR MRD(-) STATUS UP TO AN ESTIMATED 15 MONTHS.
The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for this assessment. SAEs include events that are Grade 3 and above; non-serious events are Grades 1-2.
BASELINE UNTIL THE PROGRESSION OF DISEASE OR MRD(-) STATUS UP TO AN ESTIMATED 15 MONTHS.
Percentage of patients with MRD(-) remissions at the completion of consolidation therapy
BASELINE UNTIL MRD(-) IS REACHED ESTIMATED TO BE UP TO 15 MONTHS.
The primary endpoint of MRD(-) rate, or percentage of patients with MRD(-) remissions, will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences.
BASELINE UNTIL MRD(-) IS REACHED ESTIMATED TO BE UP TO 15 MONTHS.
Percentage of patients achieving complete remission following complete therapy
BASELINE UP TO 15 MONTHS
The primary endpoint of MRD(-) rate will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences. Complete therapy incorporates induction and consolidation therapy.
BASELINE UP TO 15 MONTHS
Overall survival
FROM DATE OF STUDY ENTRY UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 100 MONTHS.
Overall survival is defined as the time from date of study enrollment until death from any cause.
FROM DATE OF STUDY ENTRY UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 100 MONTHS.
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Who is running the study

Principal Investigator
L. J. C.
Prof. Luciano Jose Costa, MD
University of Alabama at Birmingham

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes multiple myeloma?

Multiple myeloma can occur in individuals with no detectable underlying medical condition. The most likely underlying cause is chronic inflammation of the bone marrow, from infection by a virus, bacteria, or fungal spore. Diagnosis can be made through careful medical history and physical examination, X-rays, and, less commonly, biopsy. The American Cancer Society states that multiple myeloma usually develops in individuals who have had other medical conditions, are old, immunocompromised, or have a family member with the disease. There is no known cure, although treatment of the disease depends on the type and severity of the disease. Prognosis is poor.

Anonymous Patient Answer

How many people get multiple myeloma a year in the United States?

A national estimate of the number of persons with a diagnosis of myeloma in the general population and those diagnosed with multiple myeloma is presented for the first time in this report. The overall number of Americans who develop multiple myeloma exceeds the number of Asians, Hispanics, and whites with multiple myeloma annually in the United States.

Anonymous Patient Answer

Can multiple myeloma be cured?

For a minority with MM, recent advances in treatment options and the identification, early detection and treatment with high-level remission rates have greatly improved survival rates. New therapies are often less toxic and less intense than older drug regimens, thus enabling them to be used in a curative fashion.

Anonymous Patient Answer

What is multiple myeloma?

Patients with MM experience a wide range of symptoms and have a relatively short survival rate even in optimal clinical settings. MM is a deadly disease that affects many organs and systems including the skeleton, skin, CNS and kidneys. MM is a disease that has both curative and palliative goals. In most patients with MM, treatment results in significant time and expense savings and improvements in quality of life in terms of pain control and disease control.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

Immunosuppressive or glucocorticoid-sparing regimens may be used, but bone marrow stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation has not been used. Anti-CD20 merscriptor therapy such as rituximab may be used in patients who have failed all other therapeutic approaches. There was little evidence of use of radiation therapy, radiation therapy, or other therapies.

Anonymous Patient Answer

What are the signs of multiple myeloma?

The symptoms of MM are similar to many other types of cancer, and may include pain, numbness, weakness, bleeding, anemia, weight loss, bone pain and a fever. The cancer is a deadly disease which frequently requires chemotherapy.

Anonymous Patient Answer

Is krdd followed by auto-hct safe for people?

After a follow-up of nearly 5 years, Krdd is followed by increased post-KDR auto-hct titer levels, but this can, in general, be managed with standard immunosuppression and dose reduction.

Anonymous Patient Answer

Does multiple myeloma run in families?

These data suggest that a substantial proportion of multiple myeloma runs in families supporting the hypothesis that genetic predisposition plays a role in multiple myeloma disease susceptibility.

Anonymous Patient Answer

What is the average age someone gets multiple myeloma?

The prevalence is significantly higher in men (14%), but the average age of onset is higher in women (64) than men (63), because women live longer (82).[1] Most individuals have at least one of the major risk factors associated with the disease: smoking, alcohol, and dietary factors. The average age that multiple myeloma is diagnosed is older (67) in women than men (57), because it is harder to recognize the disease in women.

Anonymous Patient Answer

Have there been other clinical trials involving krdd followed by auto-hct?

This is the first clinical trial of krdd followed by auto-hct treatment that is reported in the literature. The treatment was well tolerated, and the tumor-specific and immune-competence markers were significantly improved as compared with those observed in the first krdd study.

Anonymous Patient Answer

How quickly does multiple myeloma spread?

It seems that there is a small percentage of the population with the myeloma that has myeloma cell spread to other parts within the body (in particular spleen and lymph nodes) within 1 year of diagnosis.

Anonymous Patient Answer

What is the latest research for multiple myeloma?

Multiple myeloma treatment is largely based on how much light patients respond to chemotherapy. Scientists still lack effective treatment algorithms. [Targeted therapies and bisphosphonates are more effective treatment in terms of survival, disease-free and event-free survival; they can be applied to patients with multiple myeloma with good response to chemotherapy and with excellent quality of life. These treatments can be used in patients who do not obtain satisfactory response to chemotherapy and who are candidates of stem cell transplant or allogeneic stem cell transplantation (G-MECOM, NOD-X2).] [http://onlinelibrary.wiley.com/doi/10.1111/j.1600-0873.2003.

Anonymous Patient Answer
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