Daratumumab (Darzalex)
Anti-CD38 monoclonal antibody for multiple myeloma; used in frontline and relapsed disease.
What is Daratumumab?
What it targets
CD38 protein found at high levels on myeloma cells. Daratumumab binds to CD38 and triggers immune-mediated killing of cancer cells.
Who it may help
Adults with newly diagnosed or relapsed multiple myeloma with adequate organ function, blood counts, and performance status.
Why testing matters
Hepatitis B screening, blood group typing, and baseline blood counts are required before starting Daratumumab to ensure safety and monitoring.
Which cancers can Daratumumab treat?
Daratumumab is approved for several settings in multiple myeloma and is used in selected patients with AL amyloidosis in some countries.
| Newly diagnosed multiple myeloma (frontline) | FDA and EMA approved in combination regimens for transplant-eligible and transplant-ineligible patients; deepens treatment response in multiple frontline regimens. |
| Relapsed or refractory multiple myeloma | Approved after prior treatment lines in combination with other anti-myeloma agents; active after exposure to proteasome inhibitors and IMiDs. |
| High-risk smouldering multiple myeloma | Subcutaneous Daratumumab received EMA approval in 2025 for selected adults with high-risk smouldering myeloma; local eligibility and availability must be confirmed. |
| AL amyloidosis (selected patients) | Daratumumab-based therapy may be used in selected patients in some countries; depends on indication, local approval, and organ function — confirm with your specialist. |
Are you eligible for Daratumumab?
Eligibility depends on confirmed multiple myeloma diagnosis, disease stage, treatment history, organ function, and overall performance status.
- Confirmed diagnosis of multiple myeloma by bone marrow biopsy and standard laboratory testing
- Newly diagnosed myeloma where a Daratumumab-based frontline regimen is planned
- Relapsed or refractory myeloma after prior anti-myeloma treatment
- Adequate blood counts: sufficient white cells, red cells, and platelets before starting
- Adequate kidney and liver function for the planned combination regimen
- Hepatitis B status confirmed; antiviral prophylaxis required if prior hepatitis B exposure
- No active uncontrolled serious infection at the time of starting treatment
- Performance status adequate to tolerate the planned combination and monitoring schedule
How does Daratumumab work?
- Targeting CD38 on myeloma cells
- Activating the immune system
- Direct effects on myeloma cell biology
- Combination synergy with other myeloma drugs
Daratumumab was the first anti-CD38 monoclonal antibody approved in oncology, marking a turning point in how multiple myeloma is treated.
Tests required before starting Daratumumab
These tests confirm the myeloma diagnosis, establish treatment response baselines, and identify safety issues that must be addressed before the first dose.
| Bone marrow biopsy | Confirms myeloma diagnosis, plasma cell percentage, and cytogenetic risk profile including high-risk features such as del17p, t(4;14), or t(14;16). |
| Serum protein electrophoresis and free light chains | Establishes the M-protein baseline for monitoring treatment response; immunofixation confirms the myeloma immunoglobulin type. |
| Hepatitis B screening (HBsAg, anti-HBc) | Mandatory before starting; Daratumumab can cause hepatitis B reactivation, including in patients with past resolved infection. |
| Blood group typing and antibody screen | Daratumumab interferes with blood bank compatibility testing; must be completed before the first dose and result documented in the patient record. |
| Complete Blood Count (CBC) | Baseline blood counts required; monitored regularly during treatment to detect neutropenia, anemia, or thrombocytopenia. |
| Kidney function tests (creatinine, eGFR) | Required for dosing decisions and to monitor kidney involvement, which is common in multiple myeloma. |
| Liver function tests | Baseline assessment required before starting and monitored during treatment. |
| Imaging (PET-CT, whole-body CT, or MRI) | Assesses bone lesions, extramedullary disease, and myeloma extent when clinically indicated; used at diagnosis and for response assessment. |
How is Daratumumab given?
Daratumumab is given as an intravenous infusion or subcutaneous injection at a hospital or infusion centre, depending on which formulation is available and prescribed.
| IV Darzalex — dose | 16 mg/kg body weight by intravenous infusion; exact schedule depends on the combination regimen and treatment phase. |
| SC Darzalex Faspro — fixed dose | 1800 mg Daratumumab with 30,000 units hyaluronidase by subcutaneous injection; takes approximately 3 to 5 minutes to administer. |
| Schedule — induction phase | Typically weekly for the first 8 doses (cycles 1 to 2), then every 2 weeks for cycles 3 to 6, then every 4 weeks; varies by regimen. |
| Pre-medication | Antihistamine, corticosteroid, and antipyretic are given before each dose to reduce the risk of infusion or injection-related reactions. |
| Infection prophylaxis | Antiviral prophylaxis such as acyclovir or valacyclovir is often prescribed alongside Daratumumab to prevent herpes zoster reactivation. |
| Missed dose | Contact your oncologist immediately if a dose is delayed or missed; do not skip or delay doses without medical advice. |
| Duration | Treatment continues until disease progression or unacceptable side effects, as determined by your oncologist based on response and regimen. |
Clinical evidence and benefits of Daratumumab
Daratumumab-based regimens have demonstrated significant clinical benefits in large randomised trials across both newly diagnosed and relapsed multiple myeloma settings.
| Deeper responses in frontline myeloma | Adding Daratumumab to standard frontline regimens has substantially increased rates of minimal residual disease negativity, a marker of deep treatment response that correlates with better long-term outcomes. |
| Prolonged progression-free survival in relapsed disease | In relapsed myeloma trials, Daratumumab-based combinations have significantly extended the time before disease progression compared with standard doublet regimens. |
| Active across transplant eligibility groups | Daratumumab-based regimens are approved for a broad range of newly diagnosed patients, whether or not they are eligible for stem cell transplant, offering treatment flexibility. |
| Non-chemotherapy antibody mechanism | As a monoclonal antibody, Daratumumab does not cause hair loss, severe mucositis, or certain other side effects associated with traditional cytotoxic chemotherapy. |
| New option in high-risk smouldering myeloma | In Europe, subcutaneous Daratumumab is now approved for selected high-risk smouldering myeloma patients, offering the possibility of delaying progression to active myeloma disease. |
Individual responses vary. Benefits reflect published clinical trial data and may not apply to every patient. Discuss expected outcomes with your oncologist.
Side effects of Daratumumab
Daratumumab is generally better tolerated than traditional chemotherapy, but it has its own side effect profile. Most effects are manageable with appropriate pre-medication, monitoring, and supportive care.
| Infusion-related reactions | Most common during the first infusion; symptoms may include chills, cough, throat tightness, runny nose, nausea, or low blood pressure; less frequent with the subcutaneous formulation. |
| Fatigue | Very common; often manageable and may improve after the first few cycles once the body adjusts to treatment. |
| Upper respiratory tract infection | Cough, nasal congestion, or cold-like symptoms; occurs more frequently due to changes in immune cell populations caused by Daratumumab. |
| Neutropenia (low white blood cells) | Can increase infection risk; monitored by regular blood counts; may require growth factor injections or temporary dose adjustment. |
| Anemia (low red blood cells) | May cause fatigue and breathlessness; monitored regularly; transfusion or erythropoiesis-stimulating agents may be used in severe cases. |
| Thrombocytopenia (low platelets) | May increase bleeding risk; monitored regularly; platelet transfusion may be required if counts fall very low. |
| Peripheral neuropathy | Risk is higher when Daratumumab is combined with bortezomib; symptoms include numbness, tingling, or pain in hands and feet. |
| Nausea or diarrhea | Generally mild; usually managed with standard anti-nausea or anti-diarrheal medicines as needed. |
| Musculoskeletal pain | Back pain, bone pain, or joint discomfort; fairly common; typically managed with standard analgesics. |
| Increased infection risk | Including pneumonia and herpes zoster reactivation; anti-infective prophylaxis is often prescribed alongside treatment. |
Contact your doctor immediately if you develop:
- Breathing difficulty, chest tightness, or severe throat tightening during or after infusion
- High fever above 38.5°C with chills, sweating, or other signs of serious infection
- Unusual bleeding, bruising, or petechiae suggesting very low platelet count
- Yellowing of the eyes or skin, dark urine, or severe abdominal pain suggesting liver problems
- Sudden severe weakness, dizziness, or near-collapse
- Fatigue, loss of appetite, or jaundice that may indicate hepatitis B reactivation
Safety precautions and drug interactions
Tell your oncologist and pharmacist about all medicines, supplements, herbal products, and health conditions before starting Daratumumab.
- Hepatitis B screening is mandatory before starting; active hepatitis B requires management before treatment can begin
- Past hepatitis B exposure requires antiviral prophylaxis during treatment and for several months after stopping
- Daratumumab interferes with blood bank testing; carry a medical card informing any emergency team of your treatment
- Inform any blood bank or transfusion service you are on Daratumumab before blood typing or crossmatch procedures
- Pregnancy is contraindicated; effective contraception required during treatment and for at least 3 months after the last dose
- Breastfeeding should be avoided during treatment and for a defined period after stopping; discuss timing with your oncologist
- Live vaccines must not be given during Daratumumab treatment; discuss timing of inactivated vaccines with your doctor
- Tell your doctor about lung conditions such as asthma or COPD, as infusion reactions may worsen breathing problems
Daratumumab combination treatments
Daratumumab is nearly always used in combination with other anti-myeloma medicines; the best combination depends on transplant eligibility, prior treatment exposure, and disease risk.
| Dara + bortezomib + thalidomide + dexamethasone | Frontline therapy for transplant-eligible myeloma; deepens pre-transplant response depth and MRD negativity rates. |
| Dara + bortezomib + lenalidomide + dexamethasone | Frontline four-drug regimen for selected transplant-eligible or high-risk patients; approved in several regions. |
| Dara + lenalidomide + dexamethasone | Frontline therapy in transplant-ineligible patients and relapsed myeloma; one of the most widely used Daratumumab regimens. |
| Dara + bortezomib + melphalan + prednisone | Frontline regimen for transplant-ineligible patients; approved in many regions as an alternative to IMiD-based combinations. |
| Dara + pomalidomide + dexamethasone | Relapsed or refractory myeloma, particularly after prior lenalidomide-based therapy; approved for this setting. |
| Dara + carfilzomib + dexamethasone | Relapsed or refractory myeloma; approved for patients who received at least one prior line; active in lenalidomide-refractory disease. |
If Daratumumab stops working
Resistance to Daratumumab can develop over time; understanding the mechanisms helps oncologists choose the most appropriate next-line treatment.
| Loss of CD38 surface expression | Myeloma cells can reduce surface CD38 levels during treatment, making Daratumumab less effective at binding and immune recruitment — a key primary resistance mechanism. |
| Alternative myeloma survival pathways | Myeloma cells may activate alternate survival signals that bypass CD38-mediated killing, allowing disease to progress despite ongoing Daratumumab treatment. |
| Cytogenetic evolution and high-risk features | Emergence of high-risk cytogenetic changes such as del17p during treatment can signal acquired resistance and a more aggressive disease course. |
| Next-line options after anti-CD38 therapy | BCMA-directed therapies including CAR T-cell therapy, bispecific antibodies such as teclistamab, belantamab mafodotin, selinexor, and clinical trials. |
| Second opinion at relapse | A second opinion at a specialist myeloma centre is strongly recommended when myeloma progresses after Daratumumab to evaluate newer agents and trials. |
Cost of Daratumumab by country
Daratumumab is a branded biologic with no widely approved biosimilar as of 2026; costs vary significantly by country, formulation, combination regimen, and insurance coverage.
| India | Available at major oncology centres; institutional pricing and patient assistance programmes may apply; full treatment cycles represent a significant financial commitment without support. |
| USA | Brand-name Darzalex is expensive per cycle; Janssen CarePath patient assistance programme is available for eligible patients; insurance coverage varies by plan and indication. |
| UK and Europe | Covered by NHS in the UK for approved indications; reimbursed in most major EU health systems within approved combination regimens. |
| China | Available at leading cancer hospitals; international patients can access through coordinated hospital arrangements; pricing differs from local national reimbursement rates. |
| Singapore and South Korea | Available at approved speciality cancer centres; insurance coverage and co-payment requirements vary by plan, indication, and treatment line. |
Availability of Daratumumab globally
Daratumumab is available in many major markets as branded Darzalex or Darzalex Faspro; no generic or biosimilar is widely approved as of 2026.
India
Available at major oncology and haematology centres in metropolitan cities. No generic approved. Institutional programmes and Janssen support may assist with access. Confirm availability with your oncologist or CancerFax.
USA
FDA-approved for multiple myeloma indications. Available through hospital pharmacies and specialty distributors. Janssen CarePath patient assistance programme available for eligible patients.
China
Available at leading cancer hospitals in Beijing, Shanghai, Guangzhou, and other major cities. International patients can access through coordinated hospital admission arranged by CancerFax.
Europe
EMA-approved for multiple myeloma. Subcutaneous formulation also approved in 2025 for high-risk smouldering myeloma. Reimbursed in most major EU national health systems.
Singapore and South Korea
Approved and available at speciality cancer centres. Reimbursement and co-payment requirements vary by plan, indication, and treatment line. Confirm local access with your oncologist.
Daratumumab in current clinical trials
Active research is exploring earlier disease settings, new combinations, and optimal sequencing of Daratumumab with the latest generation of myeloma therapies.
| MRD-guided treatment strategies | Trials using minimal residual disease negativity to guide when to intensify, de-escalate, or stop Daratumumab-based therapy in newly diagnosed myeloma. |
| Maintenance therapy after transplant | Studies assessing single-agent Daratumumab maintenance after autologous stem cell transplant to prolong remission compared with placebo or alternative maintenance drugs. |
| Sequencing with BCMA-directed therapies | Trials examining the optimal sequence of anti-CD38 therapy and BCMA-directed agents including CAR T-cell therapy and bispecific antibodies in relapsed myeloma. |
| Expanded smouldering myeloma studies | Further studies in high-risk smouldering myeloma following the 2025 European approval, evaluating long-term outcomes of early Daratumumab intervention. |
Your treatment journey with Daratumumab
Myeloma diagnosis and baseline testing
Risk stratification and transplant assessment
Pre-treatment safety screening
Starting Daratumumab-based treatment
Response monitoring during treatment
Transplant, continuation, or maintenance
Monitoring for relapse and next-line planning
Questions to ask your oncologist about Daratumumab
- Is Daratumumab the right treatment for my stage and type of myeloma?
- Will I receive IV Darzalex or the subcutaneous Darzalex Faspro formulation?
- What combination of drugs will be given alongside Daratumumab?
- Do I need hepatitis B screening before starting, and will I need antiviral tablets?
- How will Daratumumab affect blood transfusion or blood type testing?
- How will we know whether the treatment is working?
- What side effects should I report to you urgently?
- What are my options if myeloma progresses during or after Daratumumab?
How CancerFax supports Daratumumab patients
CancerFax helps myeloma patients navigate Daratumumab access, understand their reports, and connect with specialist oncologists in India, China, and internationally.
| Report review | Upload bone marrow biopsy, protein electrophoresis, free light chains, CBC, or hepatitis B results — our team reviews and explains what they mean for Daratumumab eligibility. |
| Specialist connection | We connect myeloma patients with haematologists and oncologists experienced in Daratumumab-based regimens in India, China, Singapore, and internationally. |
| Second opinion | If myeloma is progressing or you are deciding between treatment regimens, CancerFax arranges a specialist second opinion from a myeloma expert at a leading centre. |
| Cost and access navigation | We help patients understand Daratumumab costs, patient assistance programmes, and hospital availability in India, China, and other countries where access is needed. |
| Clinical trial guidance | For relapsed, refractory, or high-risk myeloma patients, CancerFax helps identify relevant clinical trials where newer agents or experimental combinations may be available. |
| International coordination | For patients seeking Daratumumab treatment or second opinions abroad, CancerFax handles full hospital coordination, logistics, and communication from start to finish. |
Frequently asked questions about Daratumumab
Common questions from multiple myeloma patients and caregivers
No. Daratumumab is a monoclonal antibody, not traditional chemotherapy. It targets the CD38 protein on myeloma cells and recruits the immune system to destroy them. Unlike chemotherapy, it does not directly attack all dividing cells, so its side effect profile is different. It is usually combined with other anti-myeloma drugs, some of which may be targeted agents or traditional treatments.
The first IV infusion of Daratumumab is typically the longest, often 7 to 8 hours, because the drip rate is started slowly to reduce infusion reactions. Later infusions can be shorter, often 4 to 6 hours, as the rate is increased if earlier doses were tolerated well. The subcutaneous formulation (Darzalex Faspro), where available, takes only about 3 to 5 minutes to administer, significantly reducing clinic time.
IV Daratumumab must be given at a hospital or infusion centre with access to emergency equipment because infusion reactions can occur. The subcutaneous formulation is still typically administered at a medical facility with monitoring, especially for the first several doses. Home administration is not generally recommended. Your oncologist will advise based on your response history and local practice.
Daratumumab binds to the CD38 protein, which is also present in small amounts on normal red blood cells. This causes a false positive result in blood bank compatibility tests, making it appear as though the patient's blood reacts with all donor blood. This effect can last 6 months or more after stopping Daratumumab. Patients must have blood typing done before the first dose and should carry a medical alert card informing any future transfusion team about their treatment.
Yes. Sorafenib is available as generic versions in several countries, including India, where it has an important history linked to the country's first compulsory licence for a cancer drug. Generic sorafenib contains the same active ingredient at the same dose and has been used widely. Ask your oncologist or pharmacist about generic availability and legitimate sourcing in your country. CancerFax can also help with access guidance across India, China, and other regions.
Myeloma progression after Daratumumab-based therapy is typically managed by switching to a regimen targeting a different pathway. Options may include BCMA-directed CAR T-cell therapy, bispecific antibodies such as teclistamab, belantamab mafodotin, selinexor, or a clinical trial. Your oncologist will review your prior drug exposures, cytogenetic risk, organ function, and fitness to decide the best next step. A second opinion from a specialist myeloma centre is often recommended at this stage.
No. Daratumumab should not be used during pregnancy as it may harm the developing baby, including effects on immune cell development. Women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose. Breastfeeding should also be avoided during treatment and for a period after stopping. Always inform your oncologist if you are pregnant, planning to become pregnant, or breastfeeding before starting myeloma treatment.