BridgeMD
New treatment option for Multiple Myeloma
Official title VitD3 Supplementation in Patients With Multiple Myeloma
ClinicalTrials.gov ID: NCT05846880
What this study is testing
What is Lenalidomide?
Lenalidomide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for multiple myeloma.
Also referred to as Revlimid.
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
- The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive Maintenance Vitamin D and the other arm will receive no maintenance Vitamin D prior to ASCT.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must be ≥ 18 years of age at time of registration to Step 1.
- Patients must have history and physical exam within 28 days prior to registration.
- Patients must have Zubrod/ECOG Performance Status ≤ 2.
- Patients must have had a confirmed diagnosis of symptomatic MM (See Section 4.1) with measurable disease at the time of myeloma diagnosis that...
- Patients must be willing and able to take DVT prophylaxis (aspirin, low molecular weight heparin, warfarin, or equivalent oral anticoagulation) and...
You likely can't join if
- Any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
- Progressive disease at any time prior to registration.
- Intolerance to the starting dose of lenalidomide (10 mg).
- Prior allograft, prior organ transplant requiring immunosuppressive therapy, or have already received a previous autologous transplantation (e.g...
- Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated...
- Received any investigational agents within 14 days prior to registration.
See the full eligibility criteria
- Patients must be ≥ 18 years of age at time of registration to Step 1.
- Patients must have history and physical exam within 28 days prior to registration.
- Patients must have Zubrod/ECOG Performance Status ≤ 2.
- Patients must have had a confirmed diagnosis of symptomatic MM (See Section 4.1) with measurable disease at the time of myeloma diagnosis that required systemic induction therapy prior to ASCT. Measurable disease is...
- Patients must be willing and able to take DVT prophylaxis (aspirin, low molecular weight heparin, warfarin, or equivalent oral anticoagulation) and comply with lenalidomide REMS program requirements.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration. FCBP must agree to have a second pregnancy...
- Patients must have evidence of adequate renal function, as defined by (1) creatinine clearance (CrCl) ≥ 10 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula. Values must...
- Patients must have adequate hepatic function defined by the following within 28 days prior to registration: Total bilirubin ≤ 1.5 x IULN (institutional upper limit of the norm) and AST and ALT ≤ 3.0 x IULN
- Patients must be acceptable for transplant per institutional guidelines:
- Patient's with human immunodeficiency virus (HIV) are eligible providing they are on effective antiretroviral therapy and have undetectable viral load at their most previous viral load test and within 6 months prior to...
- Patients must be able to take and swallow oral medication (capsules) whole.
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- Any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
- Progressive disease at any time prior to registration.
- Intolerance to the starting dose of lenalidomide (10 mg).
- Prior allograft, prior organ transplant requiring immunosuppressive therapy, or have already received a previous autologous transplantation (e.g., requiring second ASCT at time of screening).
- Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete...
- Received any investigational agents within 14 days prior to registration.
- Seropositive for Hepatitis B
- Seropositive for Hepatitis C
- Hypercalcemia (serum calcium level \> 10.3 mg/dL) (institutional upper limit of the norm) at time of study entry.
- Patients refractory to lenalidomide.
- Patients that have received any investigational agents within 14 days prior to registration.
- Any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption...
The study team makes the final eligibility decision.
Where it's taking place
- Augusta, Georgia, 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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augusta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.