PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and/or Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 70 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Multiple Myeloma, Complication

Being tested

Interpretation of the results from the detection visit, Explaining detection results and referrals to the patient, Early medical care through the network, Transmission of results from each detection visit to the referring onco-haematologists - Control Group

Keywords

Multiple Myeloma, Complications, Detection, Intervention, Autologous stem cell transplant, Randomized controlled trials

Medical subject headings

Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Interpretation of the results from the detection visitBehavioural

  • An interpretation of the results of the detection tests concerning
  • the 7 complications of interest assessed at T1, T2, T3 and T4 ;
  • the 13 secondary complications assessed at T1, T3 and T4. This interpretation will be based on decision trees (1 tree/complication) to guide investigators in their decision-making and to standardise orientations;

• Explaining detection results and referrals to the patientBehavioural

  Explanation of results and directions to the patient using plain language;The aims of this call are as follows:

  • Clearly explain the results of the detection visit and the action to be taken for each referral;
  • Evaluate the help to be given to the patient. This help will consist of making bookings with a healthcare professional in the PASCA network;
  • Reassure patients about their results, but also make them aware of the importance of taking action to improve or prevent the onset of complications.

• Early medical care through the networkBehavioural

  Early, proactive medical care through a network of dedicated healthcare professionals.

• Transmission of results from each detection visit to the referring onco-haematologists - Control GroupBehavioural

  For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective): all the data from each detection visit will be sent to the referring onco-haematologists, so that they can initiate their own management.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. change from Baseline high blood pressure

   blood pressure ≥ 140/90 mmHg measured in the investigating center and persisting over time

   Measured: month 2, month 4, month 14 and month 24

2. Change from Baseline chronic kidney failure incidence at 24 months

   diagnosed on the basis of 2 blood tests carried out within 3 months with the same technique showing either:

   • a decrease in GFR to < 60ml/min/1.73m2, estimated from serum creatinine using the CKD-EPI equation (Chronic Kidney Disease EPIdemiology collaboration, Levey, 2009),
   • positive proteinuria or albuminuria (albuminuria/creatinine ratio),
   • haematuria with a GR > 10/mm3 or 10,000/ml (after eliminating a urological cause),
   • leucocyturia with a WBC >10/mm3 or 10,000/ml (in the absence of infection),
   • a morphological abnormality on renal ultrasound: size asymmetry, bumpy contours, small kidneys or large polycystic kidneys, nephrocalcinosis, cyst.

   The evolutionary character corresponds to one of the following situations:

   • Annual decline in GFR ≥ 5 ml/min/1.73 m²/year: GFR year n - GFR year n+1
   • Presence of albuminuria,
   • Poorly controlled arterial hypertension

   Measured: month 2, month 4, month 14 and month 24

3. Change from Baseline chronic pain incidence at 60 months

   pain felt for more than 3 months by the patient with an intensity on the Visual Analogue Scale (VAS) ≥ 3

   Measured: month 2, month 4, month 14 and month 24

4. Change from Baseline sexual disorders incidence at 24 months

   at least one perceived problem among the following:

   • disorders of desire,
   • arousal/erection disorders in men,
   • arousal disorders (insufficiency) in women,
   • Orgasm disorders in women

   Measured: month 2, month 4, month 14 and month 24

5. Change from Baseline osteoporosis incidence at 24 months

   T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur

   Measured: month 2, month 14 and month 24

6. Change from Baseline chronic fatigue incidence at 24 months

   Questionnaire "MFI-20" (Multidimensional Fatigue Inventory)

   Measured: month 2, month 4, month 14 and month 24

7. Change from Baseline severe anxiety disorder incidence at 24 months

   Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)

   Measured: month 2, month 4, month 14 and month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted17 Jul 2023
2. Study start19 Jan 2024
3. Primary completion14 Jun 2028 (estimated)
4. Study completion14 Sep 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Multiple MyelomaStudies of the same condition, open and under way.
• More trials run by Centre Leon BerardThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.