Multiple Myeloma study: Lenalidomide
Official title Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing
ClinicalTrials.gov ID: NCT07485647
What this study is testing
What is Daratumumab and Recombinant Human Hyaluronidase?
Daratumumab and Recombinant Human Hyaluronidase is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as Darzalex Faspro.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests daratumumab given at a reduced frequency with lenalidomide for maintenance therapy for the cost effective treatment of patients with multiple myeloma post stem cell transplant. Darzalex Faspor (also known as Daratumumab-hyaluronidase) is a combination of two drugs used alone or with other drugs to treat adults with certain types of multiple myeloma or light chain amyloidosis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Signed and dated written informed consent
- Male or female newly diagnosed multiple myeloma (NDMM) patients 18 to 70 years old on the day of signing informed consent who had ASCT with post-ASCT...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients with high-risk and international staging system (ISS) stage-III disease in 15% of the intent to treat population.
- Absolute neutrophil count, ≥ 1.0 × 10\^9/L
You likely can't join if
- Corrected serum calcium, ≤ 14.0 mg/dL (≤ 3.5 mmol/L)
- Platelet count, ≥ 50 × 10\^9/L (≥ 50 × 10\^9/L if ≥ 50% of the bone marrow was infiltrated with multiple myeloma [MM] cells)
- Alanine aminotransferase and aspartate aminotransferase levels \< 2.5 times the upper limit of normal
- Creatinine clearance ≥ 30 mL/min (per institutional standard)
- All ASCT-related toxicities must have recovered to ≤ grade 1 (except for alopecia, fatigue and amenorrhea) prior to first randomization
- Mucositis and gastrointestinal symptoms must have resolved to ≤ grade 1
See the full eligibility criteria
- Signed and dated written informed consent
- Male or female newly diagnosed multiple myeloma (NDMM) patients 18 to 70 years old on the day of signing informed consent who had ASCT with post-ASCT response of partial response (PR) or better as defined by...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients with high-risk and international staging system (ISS) stage-III disease in 15% of the intent to treat population.
- Absolute neutrophil count, ≥ 1.0 × 10\^9/L
- Platelets ≥ 75,000/μL
- Hemoglobin level ≥ 7.5 g/dL
- Total bilirubin \< 1.5 times institutional upper limit of normal (ULN) (if patient has known history of Gilbert's syndrome, total bilirubin will not be used as an
- Corrected serum calcium, ≤ 14.0 mg/dL (≤ 3.5 mmol/L)
- Platelet count, ≥ 50 × 10\^9/L (≥ 50 × 10\^9/L if ≥ 50% of the bone marrow was infiltrated with multiple myeloma [MM] cells)
- Alanine aminotransferase and aspartate aminotransferase levels \< 2.5 times the upper limit of normal
- Creatinine clearance ≥ 30 mL/min (per institutional standard)
- All ASCT-related toxicities must have recovered to ≤ grade 1 (except for alopecia, fatigue and amenorrhea) prior to first randomization
- Mucositis and gastrointestinal symptoms must have resolved to ≤ grade 1
- All patients with concomitant amyloidosis or plasma cell leukemia
- Patient is pregnant or breastfeeding
- Has received a live vaccine within 30 days prior to first dose of study treatment. \ Examples of prohibited live vaccines include but are not limited to: measles, mumps, rubella, varicella/zoster (chicken pox), yellow...
- Is currently participating in or within 4 weeks prior to receiving first dose of study treatment in a study of an investigational agent or investigational device.
- Diagnosis of immunodeficiency; or is receiving systemic steroid therapy exceeding 10 mg daily prednisone equivalent dose (=10mg is acceptable)
- Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to first dose of study treatment.
- Radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator and radiology review
- Recipient of previous allogeneic tissue/solid organ transplant
- Known severe hypersensitivity (≥ grade 3) to drug daratumumab or lenalidomide
- History of myocarditis or pericarditis or other known underlying heart disease that is clinically significant by investigator judgment (for example, cardiomyopathy, congestive heart failure with New York Heart...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection/sepsis, or psychiatric illness/social situations that would limit compliance with study requirements
- Active autoimmune disease with immunodeficiency as a clinical component (for example, rheumatoid arthritis, systemic lupus erythematosus [SLE], ulcerative colitis, Crohn's disease, multiple sclerosis [MS], ankylosing...
- Recognized immunodeficiency disease including cellular immunodeficiencies; hypogammaglobulinemia or dysgammaglobulinemia; or acquired, hereditary, or congenital immunodeficiencies
- Known conditions associated with immunosuppression such as uncontrolled HIV/AIDS, leukemia, lymphoma, generalized malignancy, solid organ transplant recipient, or allogeneic hematopoietic stem cell transplant recipient
- Gastrointestinal disease that may significantly alter the absorption of oral drugs
- Unable or unwilling to undergo antithrombotic prophylactic treatment
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.